[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS San Raffaele\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,165,0,25,[9,46,77,99,121,147,166,206,233,253,292,315,339,358,378,402,420,444,468,495,522,547,568,585,612],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053378","effect-of-egcg-folic-acid-vitamin-b12-and-hyaluronic-acid-on-hpv-dna-integration-100053378",false,"NCT07697196","Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration","An Interventional Study Evaluating the Effect of Epigallocatechin Gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12) and Hyaluronic Acid (HA) in Affecting the DNA Integration of Human Papilloma Virus (HPV) in Women With Persistent Infection","Inclusion Criteria:\n\n1. Age ≥ 25 years old\n2. Positive HPV DNA test with genotyping 9-24 months prior to Day 0\n3. Positive HPV DNA test with genotyping at Day 0\n4. Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as:\n\n   1. Pap test: LSIL, ASC-US.\n   2. Colposcopic impression suggestive of a low-grade lesion.\n   3. Histologic report of a colposcopic biopsy consistent with a low-grade lesion.\n5. Previous HPV vaccination (latest dose at least 24 months earlier than Day 0)\n6. Patients able to accept and sign informed consent for the study\n7. Patients able to adhere to the proposed study protocol\n\nExclusion Criteria:\n\n1. High grade cervical lesions (HSIL)\n2. Ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hCG in urine\n3. Ongoing breastfeeding\n4. Primary or secondary immunodepression due to pharmacological treatments\n5. No HPV vaccination\n6. Daily assumption of other products containing green tea\n7. Hypersensitivity or allergy to the substances contained in the supplement","FEMALE","25 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"NA","This interventional, single-center, open-label randomized clinical study evaluates the efficacy of an oral dietary supplement (Pervistop®) in women with persistent Human Papillomavirus (HPV) infection. The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7. A total of 42 women aged 25 or older with persistent HPV infection and low-grade cervical lesions will be randomized 1:1 into two groups. The treated group will receive one tablet of Pervistop® daily for six months, while the control group will follow standard clinical practice. The study aims to determine if this nutritional intervention can counteract viral persistence.",[27,28,29,30,31,32],"HPV Infection","HPV Integration","HPV Disease","HPV Genital Infection","HPV Persistence","Low Grade Squamous Intraepithelial Lesions of the Cervix","NOT_YET_RECRUITING","2026-07-06",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2028-06",{"name":43,"class":44},"IRCCS San Raffaele","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100645202","ai-technologies-for-enhanced-and-celerated-high-field-wb-mri-100645202","NCT07678320","AI Technologies for Enhanced and Celerated High-Field WB-MRI","AITECH-MRI","Inclusion Criteria:\n\n* Consecutive adults (≥18 y.o.) admitted to the UO for W MRI for screening procedure.\n* Consecutive adult male patients (≥18 y.o.) admitted to the UO for WB-MRI for screening procedure and focus on prostate.\n\nExclusion Criteria:\n\n* refused to consent\n* claustrophobia\n* metal prosthesis potentially affecting image quality",true,"ALL","18 Years",{"count":57,"type":21},600,"OBSERVATIONAL","Single-center, cross-sectional observational study assessing the feasibility of advanced accelerated MRI sequences versus standard ones in terms of image quality, diagnostic reliability, and acquisition time.",[61,62,63,64,65],"Whole Body Imaging","Prostate","MRI","Lung","Vascular",[63,67,68,69,65],"Whole Body","Accelerated Imaging","Prostate Imaging","2026-06-25",{"date":72,"type":37},"2026-07-01",{"date":72,"type":21},{"date":75,"type":21},"2029-05-01",{"name":43,"class":44},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100644776","sterify-gel-as-an-adjunct-to-non-surgical-periodontal-therapy-in-periodontitis-100644776","NCT07672665","Sterify Gel as an Adjunct to Non-Surgical Periodontal Therapy in Periodontitis","The Adjunctive Effect of a Mucoadhesive Polymeric Hydrogel to Non-surgical Periodontal Therapy: a Retrospective Analysis","Sterify","Inclusion Criteria:\n\n* Adult patients aged \\>18 years\n* Diagnosis of stage II, III, or IV periodontitis\n* Non-smokers\n* Negative medical history\n* Patients treated with scaling and root planing\u002Fminimally invasive non-surgical periodontal therapy plus mucoadhesive polymeric hydrogel\n* Patients enrolled in supportive periodontal care\n\nExclusion Criteria:\n\n* Smokers\n* Pregnancy\n* Surgical re-treatment during the maintenance period","100 Years",{"count":87,"type":21},20,"This retrospective observational study will evaluate the clinical response to Sterify Gel, a sterile mucoadhesive polymeric hydrogel, when used as an adjunct to non-surgical periodontal therapy in adult patients with stage II, III, or IV periodontitis.\n\nThe study will analyze already existing anonymized clinical records from patients treated at the Periodontal Unit of IRCCS Ospedale San Raffaele in Milan, Italy. Patients included in the analysis received scaling and root planing\u002Fminimally invasive non-surgical periodontal therapy, followed by local application of Sterify Gel into periodontal pockets with probing depth greater than 4 mm.\n\nThe main objective is to assess reduction in periodontal pocket depth from baseline to 6, 12, and 24 weeks. Other periodontal clinical parameters, including clinical attachment level, gingival recession, bleeding, plaque score, tooth mobility, and furcation involvement, will also be evaluated.",[90],"Periodontitis","2026-06-22",{"date":93,"type":37},"2026-06-29",{"date":95,"type":21},"2026-06",{"date":97,"type":21},"2026-12",{"name":43,"class":44},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100644024","effects-of-chlorhexidine-on-human-gingival-fibroblasts-100644024","NCT07669636","Effects of Chlorhexidine on Human Gingival Fibroblasts","In Vitro Effects of a New Chlorhexidine-based Solution on Human Gingival Fibroblasts Survival and Function","Inclusion Criteria:\n\n* Male or female adults aged 18 years or older.\n* Undergoing routine dental surgical procedures (e.g., tooth extraction or gingivectomy).\n* Willing and able to provide written informed consent for the use of discarded gingival tissue for research purposes.\n* Systemically healthy.\n\nExclusion Criteria:\n\n* Presence of systemic diseases.\n* Presence of relevant medical comorbidities.\n* Current smoker.\n* Refusal to provide informed consent for the use of discarded biological material.",{"count":107,"type":21},3,"This prospective in vitro study aims to evaluate the effects of two chlorhexidine-based mouthwash formulations on the survival and function of human gingival fibroblasts (hGFs). Gingival fibroblasts obtained from discarded gingival tissue collected during routine dental procedures will be cultured and exposed to different concentrations of a conventional 0.2% chlorhexidine mouthwash and a 0.2% chlorhexidine mouthwash supplemented with N-acetylcysteine (NAC) and hyaluronic acid (HA).\n\nCell viability, apoptosis, migration, and gene expression will be assessed at multiple time points using Trypan Blue exclusion assay, fluorescence-activated cell sorting (FACS), scratch assay, and quantitative real-time PCR. The study is designed to investigate the concentration-dependent effects of chlorhexidine on fibroblast viability and wound-healing-related functions and to determine whether the addition of NAC and HA may improve the biological compatibility of chlorhexidine-based formulations.",[110,111,112,113,114],"HGF","Fibroblast","Chlorhexidine","Cytotoxicity","Biocompatibility","2026-06-20",{"date":70,"type":37},{"date":72,"type":21},{"date":119,"type":21},"2026-11-01",{"name":43,"class":44},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":53,"sex":54,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100644572","m1no-study---early-identification-of-infants-with-high-type-1-diabetes-risk-for-participation-in-primary-prevention-trials-100644572","NCT07670143","M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials","Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials.","M1N0","Inclusion Criteria:\n\n* Screening is performed between the ages of 0 and 6 weeks.\n* Consent form signed by parents\u002Fguardian.\n\nExclusion Criteria:\n\n* Infants aged above 6 weeks.\n* Refusal to participate in the study","0 Weeks","6 Weeks",{"count":132,"type":21},50000,"The goal of this observational study is to identify newborns at increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies in order to determine eligibility for participation in primary prevention randomized controlled trials aimed at preventing beta-cell autoimmunity.",[135],"Type 1 Diabetes",[135,137,138,127],"Genetic Testing","Infants","2026-06-18",{"date":141,"type":37},"2026-06-26",{"date":39,"type":21},{"date":144,"type":21},"2031-06",{"name":43,"class":44},5,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100644374","monocentric-retrospective-and-prospective-observational-study-of-patients-with-colorectal-cancer-100644374","NCT07663162","Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer","CRC-R","Inclusion Criteria:\n\n1. Participant is willing and able to give informed and written consent for the participation in the study\n2. Patients affected by colorectal neoplasm (regardless of disease stage)\n3. Aged \\> 18 years\n4. Patients in clinical conditions permissive to adhere to the diagnostic-therapeutic program proposed in according to the stage of the disease\n\nExclusion Criteria:\n\n1. Pediatric population\n2. Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study\n3. Pregnancy",{"count":155,"type":21},2000,"Monocentric retrospective and prospective observational study of patients with colorectal cancer",[158],"CRC (Colorectal Cancer)","2026-06-16",{"date":161,"type":37},"2026-06-23",{"date":95,"type":21},{"date":164,"type":21},"2036-06",{"name":43,"class":44},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":54,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":184,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":45},"100642364","using-artificial-intelligence-to-detect-early-signs-of-alzheimers-disease-in-people-with-memory-concerns-100642364","NCT07652931","Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns","AHEAD: AI-driven Brain Health for Early Alzheimer's Disease Detection in Individuals With Subjective Cognitive Decline","AHEAD","Inclusion Criteria:\n\n1. Diagnosis of Subjective Cognitive Decline (SCD) according to international diagnostic criteria (Jessen et al., 2014).\n2. Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event.\n3. Normal age-, gender-, and education-adjusted performance on standardized cognitive tests used to classify mild cognitive impairment (MCI) or prodromal AD.\n4. Age greater than or equal to 40 years.\n5. Native Italian Speaker.\n6. Stable pharmacological treatment for at least 4 weeks prior to enrollment.\n7. Provision of oral and written informed consent to study participation.\n\nExclusion Criteria:\n\n1. Presence of MCI, prodromal AD, or dementia.\n2. Any major systemic, psychiatric, or neurological disturbance.\n3. Medical conditions or substance abuse that could interfere with cognition.\n4. Pacemaker and\u002For other implanted neurostimulation devices in the head\u002Fneck district.\n5. Contraindications to undergoing MRI examination.\n6. Brain damage at routine MRI, including extensive cerebrovascular disorders.\n7. Traumatic or surgical wounds that could determine a risk of infection at the site of non-invasive stimulation.\n8. Scalp alterations that could determine the spread of excessive current from the device.\n9. Known history of epilepsy (due to small risk of seizure induction from rTMS in epileptic patients).\n10. Denial of oral and written informed consent to study participation.","40 Years",{"count":176,"type":21},300,[24],"AHEAD is a prospective, longitudinal, risk-stratified single-arm interventional study enrolling 300 patients with Subjective Cognitive Decline (SCD) at IRCCS San Raffaele Hospital, Milan, Italy.\n\nThe study uses artificial intelligence (AI) to integrate multimodal data - including MRI, EEG, Optical Coherence Tomography (OCT), neuropsychological assessments, and plasma biomarkers - to identify individuals with underlying Alzheimer's disease (AD) biology and predict cognitive progression.\n\nOnly participants found to be AD plasma biomarker positive (SCD+) undergo longitudinal follow-up at 12 and 24 months. Participants classified as high risk additionally receive a 6-month personalized multidisciplinary intervention combining high-frequency transcranial magnetic stimulation (TMS), digital cognitive training, structured physical exercise, and targeted management of modifiable vascular and behavioral risk factors.",[180,181,182,183],"Subjective Cognitive Decline","Alzheimer Disease","Mild Cognitive Impairment","Cognitive Decline",[180,185,186,187,188,189,63,190,191,192,193,194,195,196,197],"Alzheimer's disease","Artificial Intelligence","Transcranial Magnetic Stimulation","Plasma biomarkers","p-tau217","EEG","Optical Coherence Tomography","Cognitive Training","Physical Exercise","Brain Health","APOE","Machine Learning","Deep Learning","2026-06-11",{"date":200,"type":37},"2026-06-17",{"date":202,"type":21},"2026-08-01",{"date":204,"type":21},"2029-08-01",{"name":43,"class":44},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":214,"targetDuration":216,"studyType":58,"phases":4,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100643399","hydrocortisone-modified-release-in-adults-real-world-monitoring-of-longitudinal-outcomes-in-congenital-adrenal-hyperplasia-100643399","NCT07622030","Hydrocortisone Modified-release in Adults: Real-world Monitoring of Longitudinal Outcomes in coNgenital Adrenal hYperplasia","Long-term Real-world Outcomes of Chronotherapy With Modified-release Hydrocortisone in Congenital Adrenal Hyperplasia","HARMONY","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Genetically confirmed diagnosis of 21-hydroxylase deficiency congenital adrenal hyperplasia;\n3. Transition from conventional glucocorticoid therapy to modified-release hydrocortisone according to routine clinical practice;\n4. Stable glucocorticoid and mineralocorticoid therapy before transition;\n5. Ability to understand study procedures and provide informed consent for prospective data collection whenever applicable\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years;\n2. Pregnancy or breastfeeding;\n3. Severe uncontrolled medical or psychiatric illness;\n4. Use of glucocorticoids for indications other than CAH;\n5. Use of drugs interfering with glucocorticoid metabolism;\n6. History of bilateral adrenalectomy",{"count":215,"type":21},100,"5 Years","Classic congenital adrenal hyperplasia (CAH) is an autosomal recessive genetic disorder caused by a defect in the enzyme cascade regulating adrenal steroidogenesis; in approximately 95% of cases the defect is located in CYP21A2, the gene encoding 21-hydroxylase, and is characterized by defective adrenal steroidogenesis and cortisol deficiency. Due to the loss of physiological cortisol feedback on the hypothalamus and pituitary corticotropic cells, ACTH secretion is increased. This results in the accumulation of 17-hydroxyprogesterone (17OHP) proximal to the enzymatic defect in steroidogenesis, which in turn stimulates overproduction of the adrenal androgen precursor androstenedione and adrenal hyperplasia.\n\nTreatment of CAH is tailored to the patient and disease severity, aiming to replace cortisol and aldosterone deficiencies while controlling androgen excess and avoiding glucocorticoid overtreatment. Immediate-release hydrocortisone administered multiple times daily remains the recommended first-line treatment in growing children, whereas adult patients are frequently treated with hydrocortisone, prednisone, prednisolone or dexamethasone.\n\nHowever, conventional glucocorticoid regimens cannot adequately reproduce the physiological circadian rhythm of cortisol secretion. In physiological conditions, ACTH-driven cortisol secretion follows a clear circadian rhythm characterized by low evening levels, nocturnal increase between 2:00 and 4:00 a.m., a morning peak upon awakening, and progressive decline during daytime.\n\nDual daytime dosing of immediate-release hydrocortisone in CAH can control ACTH-driven adrenal androgen secretion during the day; however, because of its rapid absorption into the bloodstream and short half-life, the evening dose of hydrocortisone cannot adequately suppress the nocturnal ACTH surge and ACTH-driven adrenal androgen overproduction.\n\nConsequently, patients are often exposed to supraphysiological glucocorticoid doses during nighttime hours in an attempt to control morning hyperandrogenism. The disruption of physiological cortisol homeostasis contributes to poor cardiometabolic profile, obesity, insulin resistance, impaired fertility, reduced quality of life, and increased cardiovascular morbidity and mortality observed in patients with CAH.\n\nBone health may also be impaired in patients with CAH because of chronic glucocorticoid exposure and androgen imbalance. Previous studies demonstrated reduced lumbar and femoral bone mineral density and increased fracture risk in both male and female patients.\n\nModified-release hydrocortisone (MR-HC; Efmody®) is a multiparticulate formulation developed to better reproduce physiological cortisol circadian rhythm through chronotherapy. Previous phase II and phase III studies demonstrated improved biochemical control, reduction in androgen excess, lower glucocorticoid exposure, improved fertility outcomes, and sustained long-term efficacy compared with conventional glucocorticoid regimens.\n\nHowever, real-world longitudinal data regarding long-term biochemical, metabolic, cardiovascular, reproductive and skeletal outcomes remain limited, particularly in adult patients transitioning from pediatric to adult endocrine care.\n\nThe present study is a single-center, retrospective and prospective, longitudinal, open-label observational cohort study aimed at evaluating the long-term real-world outcomes of chronotherapy with modified-release hydrocortisone in adult patients with genetically confirmed 21-hydroxylase deficiency CAH.\n\nRetrospective clinical, biochemical and radiological data already available from routine clinical care will be collected from medical records, while prospective observational follow-up will continue according to routine endocrine clinical practice.",[219],"CAH - Congenital Adrenal Hyperplasia",[221,222,223,224],"chronotherapy","hydrocortisone","21-hydroxylase deficiency CAH","outcomes","2026-06-04",{"date":227,"type":37},"2026-06-08",{"date":229,"type":21},"2026-07-31",{"date":231,"type":21},"2031-07-31",{"name":43,"class":44},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":45},"100640307","a-study-comparing-single-port-and-multi-port-robot-assisted-surgery-in-patients-with-prostate-or-kidney-renal-cancer-100640307","NCT07610083","A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer","Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer","Inclusion Criteria:\n\n* The participant provides written informed consent\n* Male or female participants who are at least 18 years of age on the day of signing informed consent\n* Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer\n* Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients\n* Suitable for RARP or RAPN.\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years\n* Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol\n* Inability to read and sign the informed consent\n* No available pre-operative staging\n* Contraindication to surgery\n* Presence of distant metastases (M1)",{"count":241,"type":21},376,"This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer.\n\nConsecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed.\n\nThe study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs.\n\nFunctional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.",[244,245],"Prostate Cancer","Renal Cancer","2026-05-20",{"date":248,"type":37},"2026-05-27",{"date":95,"type":21},{"date":251,"type":21},"2030-06",{"name":43,"class":44},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":259,"enrollmentInfo":260,"targetDuration":262,"studyType":58,"phases":4,"briefSummary":263,"conditions":264,"keywords":275,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100638708","a-retrospective-and-prospective-clinical-registry-for-data-collection-of-perimenopausal-menopausal-and-premature-ovarian-insufficiency-women-100638708","NCT07606326","A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women","Inclusion Criteria:\n\n* 1\\. Age: women aged 18-60 years at the time of enrollment and in follow up, up to 65 years old\n* 2\\. Women in Perimenopause, defined as the transitional period preceding the final menstrual period, characterized by changes in menstrual cycle regularity and\u002For the onset of menopausal symptoms. Women experience variable cycle length, skipped cycles, or amenorrhea of less than 12 months' duration, often accompanied by vasomotor symptoms, sleep disturbances, and other menopause-related complaints.\n* 3\\. Women in Menopause, defined as the permanent cessation of menstruation resulting from loss of ovarian follicular activity and is diagnosed retrospectively after 12 consecutive months of amenorrhea in the absence of other pathological or physiological causes. Women may present with persistent menopausal symptoms and\u002For long-term consequences of estrogen deficiency, including changes in bone, cardiovascular, metabolic, and genitourinary health.\n\nlt includes women in early Menopause, defined as menopause occurring before the age of 45 years, but after 40 years, in the absence of surgical or iatrogenic causes.\n\n* 4\\. Women in Premature Ovarian lnsufficiency (POI), defined as impaired ovarian function occurring before the age of 40 years, characterized by oligo- or amenorrhea, elevated gonadotropin levels, and hypoestrogenism.\n* 5\\. Women with iatrogenic menopause, caused by:\n* Bilateral oophorectomy\n* Chemotherapy or radiotherapy-induced ovarian failure\n* Other pharmacological treatments resulting in ovarian insuftficiency\n* 6\\. Women evaluated at the specialized Menopause Clinic or the Multidisciplinary Endocrinology\u002FMetabolic Disorders clinic.\n* 7\\. Data availability: for retrospective participants, sufficient medical records must be available; tor prospective participants, patients must be willing to participate in the registry and provide informed consent.\n* 8\\. All women are eligible regardless of concomitant diseases, to reflect real-world clinical practice.\n\nExclusion Criteria:\n\n* 1\\. Women unable to provide informed consent due to cognitive impairment or severe psychiatric conditions.\n* 2\\. Women already participating in interventional clinical trials affecting menopausal or metabolic management in a way that could bias observational data.\n* 3\\. Women with incomplete medical records for retrospective data collection or those refusing informed consent for prospective enrollment.","65 Years",{"count":261,"type":21},5000,"20 Years","This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders.\n\nThe registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice.\n\nClinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, as well as imaging data routinely used in clinical practice, will be recorded when available.\n\nEnrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance.\n\nThe registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.",[265,266,267,268,269,270,271,272,273,274],"Menopause","Menopausal Hormone Therapy","Menopause Surgical","Menopause Related Conditions","Menopausal Complaints","Menopausal Osteoporosis","Menopause-related Hot Flashes","Menopausal and Perimenopausal Disorder, Unspecified","Menopausal and Postmenopausal Women","Premature Ovarian Failure (POF)",[276,277,278,279,280,281,282,283,284],"menopause","perimenopause","premature ovarian failure","hormonal replacement teraphy","osteoporosis","genitourinary syndrome of menopause","hot flashes","menopausal discomfort","menopausal symptoms","2026-05-19",{"date":287,"type":37},"2026-05-26",{"date":95,"type":21},{"date":290,"type":21},"2040-12",{"name":43,"class":44},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":45},"100638779","on-treatment-single-cell-analysis-for-the-identification-of-early-tumor-response-biomarkers-on-prospective-collected-serial-tumor-biopsies-in-triple-negative-breast-cancer-patient-during-standard-neoadjuvant-chemo-immunotherapy-100638779","NCT07597642","ON-treatment Single-cell Analysis for the Identification of Early Tumor Response Biomarkers on Prospective Collected Serial Tumor Biopsies in Triple Negative Breast Cancer Patient During Standard Neoadjuvant Chemo-immunotherapy","ONSET","Inclusion Criteria:\n\n1. Female patients aged ≥18 years.\n2. ECOG performance status 0-1.\n3. Histologically confirmed early breast cancer with one of the following molecular profiles:\n\n   * TNBC: ER and PR negative (IHC \\\u003C10%) and HER2 negative (IHC 0-1+ or FISH non-amplified).\n   * High-risk luminal (ER+\u002FHER2-): ER positive (IHC ≥10%) HER2 negative (IHC 0-1+ or FISH non-amplified), with high-risk features (e.g., Grade 3, PR-negative, high proliferation, high TILS).\n4. Clinical indication for neoadjuvant treatment according to standard practice:\n\n   * TNBC: cT1c and\u002For cN positive, or cT2 (\\>2 cm) and\u002For cN positive (stage II,III).\n   * High-risk luminal: features as defined above (Grade 3, PR-negative, high proliferation, ER low).\n5. Ability to understand and sign written informed consent for participation in the study, approved by the local Ethics Committee.\n\nExclusion Criteria:\n\n1. HER2-positive tumors.\n2. Multifocal tumors - exclusion if a single index lesion cannot be identified and sampled; otherwise allowed if a representative lesion can be biopsied.\n3. Known metastatic disease. 4 Clinical contraindications to the planned neoadjuvant therapy.\n\n5\\. Decision for upfront surgery as determined by the multidisciplinary team. 6. Inability to provide informed consent. 7. Pregnancy or breastfeeding. 8. Prior systemic therapy (chemotherapy, immunotherapy, or endocrine therapy) for the current breast cancer before baseline biopsy 9. On-treatment biopsy clinically not feasible or controindicated",{"count":300,"type":21},55,[24],"This study explores early breast cancer, focusing on triple-negative and high-risk luminal subtypes. It combines single-cell RNA sequencing and spatial imaging of tumor samples collected at different time points during treatment. The aim is to better understand how cancer cells and immune cells interact and to identify biomarkers that can predict whether a patient will respond to chemo-immunotherapy or develop resistance.\n\nThe study assumes that early molecular and spatial changes at the single-cell level can predict treatment response. This knowledge could help doctors adapt therapies, avoiding unnecessary treatment while improving effectiveness. The project seeks to reveal, for the first time, how cellular diversity and spatial relationships contribute to treatment resistance and disease progression.\n\nTumor samples will be analyzed before treatment, after the first treatment cycle (C1D1), and at surgery. Only the biopsy taken after C1D1 is collected specifically for this study; all other samples come from routine clinical care.",[304],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[306,307],"triple negative breast cancer","high-risk luminal (ER+\u002FHER2neg)",{"date":309,"type":37},"2026-05-22",{"date":311,"type":21},"2026-09",{"date":313,"type":21},"2029-03",{"name":43,"class":44},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100637710","diagnostic-performance-and-quantitative-analysis-of-18ffet-pet-in-brain-tumours-100637710","NCT07599917","Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours","FET-BRAIN-DX","Inclusion Criteria:\n\n* Patients who underwent a brain PET\u002FCT or PET\u002FMRI scan with \\[18F\\]FET for clinical reasons during the study period.\n* Age ≥ 18 years.\n* Indication for the scan related to diagnosis, grading, assessment of treatment response or suspected recurrence of any brain tumour (primary or metastatic).\n* Availability of the corresponding static and dynamic images.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* . Pregnancy or breastfeeding",{"count":323,"type":21},69,"This is a retrospective study encompassing all \\[18F\\]FET PET scans performed at our centre. By analysing both static and dynamic scans, conducting in-depth kinetic modelling, and comparing quantitative parameters across different tumour types and clinical contexts, the study aims to determine the true diagnostic value of \\[18F\\]FET PET in everyday clinical practice. The ultimate goal is to identify imaging biomarkers useful for improving tumour characterisation and distinguishing recurrence from post-treatment changes, thereby strengthening the role of \\[18F\\]FET PET in modern neuro-oncology.",[326],"Brain Tumors",[328,326,329,330,331],"FET PET","Meningioma","Diagnostic Accuracy","Dynamic PET Imaging","2026-05-14",{"date":246,"type":37},{"date":335,"type":21},"2026-06-01",{"date":337,"type":21},"2026-12-31",{"name":43,"class":44},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":346,"minAge":55,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100539053","high-resolution-intra-operative-psma-pet-ct-in-prostate-cancer-100539053","NCT06298838","High-resolution Intra-operative PSMA PET-CT in Prostate Cancer","Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study","Inclusion Criteria:\n\n1. Male patient, 18 years of age or older.\n2. Patient is confirmed with high risk prostate cancer.\n3. Patient is indicated to undergo radical prostatectomy and ePLND.\n4. Patient is estimated compliant for study participation by the investigator.\n5. Patient has freely given his\u002Fher informed consent to participate in this study.\n\nExclusion Criteria:\n\n1. Patient has general or local contra-indications for radical prostatectomy.\n2. Patient has active viral or fungal infection.\n3. Patient previously received radiotherapy of the prostate.\n4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.","MALE","80 Years",{"count":349,"type":21},10,"This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .\n\nThe aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.",[244],{"date":353,"type":37},"2026-05-18",{"date":95,"type":21},{"date":356,"type":21},"2027-05",{"name":43,"class":44},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":376,"leadSponsor":377,"locationsCount":4},"100637990","eat-ing-enhancing-anticancer-treatment-safety-via-immunomodulatory-nutritional-support-in-advanced-gastrointestinal-cancers-100637990","NCT07590622","EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers","EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers: A Single-Center Randomized Trial","EAT-ING","Inclusion Criteria:\n\n1. Will to participate by providing written IC.\n2. Male or female aged 18 years or older.\n3. A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.\n4. Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.\n5. Availability to take ONS.\n6. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.\n7. An ECOG PS of 2 or less.\n8. Investigator's assessment of life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. Are under 18 years of age.\n2. Inability to sign an IC.\n3. Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;\n4. Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;\n5. Pregnancy or lactation.",{"count":367,"type":21},88,[24],"The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies in reducing the risk of post-operative complications and the length of stay of patients undergoing major cancer surgery.\n\nThe guidelines for the nutritional management of patients with cancer agree on the utility of nutritional support, whenever it is necessary, to improve clinical outcomes, and the efficacy and tolerability of treatments.\n\nTo our knowledge, this is among the first clinical trial specifically designed to evaluate the role of immunomodulants-enriched ONS in combination with nutritional counseling in reducing serious AEs rate in patients with advanced GI cancers undergoing systemic treatments.",[371],"Gastrointestinal Cancer","2026-05-13",{"date":374,"type":37},"2026-05-15",{"date":95,"type":21},{"date":144,"type":21},{"name":43,"class":44},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":399,"leadSponsor":401,"locationsCount":4},"100639113","expander-based-versus-direct-to-implant-pre-pectoral-breast-reconstruction-a-comparative-analysis-of-surgical-outcomes-100639113","NCT07593651","EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes","EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes : the EXPRESsO Study","EXPRESSO","Inclusion Criteria:\n\n* Female patients ≥18 years\n* Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer\n* Patients undergoing pre-pectoral implant-based breast reconstruction, either:\n\n  * One-stage DTI, or\n  * Two-stage TE-I\n* Use of implant with or without biological or synthetic mesh\n* Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side\n\nExclusion Criteria:\n\n* Male patients\n* Subpectoral implant-based reconstruction\n* Autologous breast reconstruction\n* Delayed reconstructions not performed at the time of mastectomy\n* Incomplete clinical or follow-up data for primary endpoint analysis",{"count":387,"type":21},276,"Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies:\n\n(i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I).\n\nEach approach is associated with specific indications, advantages, and inherent limitations.\n\nThe EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.",[390,391],"Breast Cancer","Operable Breast Cancer",[393,394,395],"breast cancer","Mastectomy","Pre-pectoral reconstruction","2026-05-11",{"date":353,"type":37},{"date":95,"type":21},{"date":400,"type":21},"2027-12",{"name":43,"class":44},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100636891","monitoring-disease-activity-in-patients-with-takayasu-arteritis-with-the-omeract-takayasu-ultrasound-score-otus-100636891","NCT07571577","Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)","A Multicenter Prospective Observational Study on the Role of the OMERACT Takayasu Ultrasound Score (OTUS) in Monitoring Disease Activity in Patients With Takayasu Arteritis","MOTUS","Inclusion Criteria:\n\n* Age ≥18 years\n* Male and female\n* Diagnosis of TAK according to the 1990 ACR and\u002For 2022 ACR\u002FEULAR classification criteria\n* Active disease, defined as the presence of at least two of the following three domains:\n\n  * Clinical domain: new onset or worsening of clinical signs and\u002For symptoms attributable to TAK;\n  * Laboratory domain: elevation of inflammatory markers, defined as ESR and\u002For CRP above the upper limit of normal according to local laboratory standards, not attributable to causes other than TAK;\n  * Imaging domain: imaging evidence of active vasculitis on modalities other than ultrasound, including FDG-PET, magnetic resonance angiography (MRA), or computed tomography angiography (CTA).\n* Ability to undergo serial vascular ultrasound assessments during follow-up\n* Provision of signed informed consent\n\nExclusion Criteria:\n\n* Inability or contraindication to undergo vascular US\n* Severe comorbidities limiting participation or follow-up\n* Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation)\n* Diagnosis of another rheumatologic disease\n* Refusal or inability to provide informed consent",{"count":215,"type":21},"This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.",[413],"Takayasu Arteritis (TAK)","2026-05-06",{"date":396,"type":37},{"date":72,"type":21},{"date":418,"type":21},"2032-12-31",{"name":43,"class":44},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":347,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":45},"100638157","preoperative-adaptive-radiotherapy-concomitant-to-chemotherapy-for-rectal-adenocarcinoma-adaptive-rectal-cancer-trial-02-100638157","NCT07580027","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02)","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02). An Interventional Study.","Inclusion Criteria:\n\nInitial phase (standard phase). These criteria represent the conditions for which preoperative chemoradiotherapy treatment for rectal cancer is clinically indicated\n\n1. Histologically confirmed rectal adenocarcinoma\n2. Microsatellite status: stable\n3. Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy\n4. Stage T3-T4N0 or any T with positive lymph nodes\n5. Lower margin of lesion no more than 12 cm from anal verge Adaptive radiotherapy phase (experimental phase)\n6. ERI\\_TCP \\\u003C 32.6 calculated as follows: ERITCP=-ln\\[(1-(Vmid\u002FVpre)\\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the images of the MR intermediate to RT)\n7. Lower margin of rectal lesion at least 1 cm from surgical resection line on images of the intermediate smc MRI\n8. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2\n9. Age: 18-80 years\n10. Written informed consent\n\nExclusion Criteria:\n\n1. Distant metastases\n2. Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance\n3. Previous chemotherapy or radiotherapy to the pelvis\n4. Contraindications to radiotherapy: active ulcerative colitis\n5. Contraindications to chemotherapy: NE\\\u003C1.5x10\u002FL, Plt \\\u003C 100x10\u002FL), creatinine \\>1,5mg\u002Fdl, bilirubin \\> 2mg\u002Fdl, AST\u002FALT \\> 3x normal upper limit, significant cardiac disease, peripheral neuropathy.\n6. Pregnancy\n7. Breastfeeding",{"count":428,"type":21},33,[24],"The aim of this clinical study is to increase the rate of pathological responses up to 70% by means of improved patient selection operated by a radiobiological index called ERI\\_TCP and by an increase in the dose of radiotherapy in the final concomitant boost of preoperative radiochemotherapy treatment for rectal adenocarcinoma.",[432],"Locally Advanced Rectal Carcinoma",[434,435],"adaptive radiotherapy","preoperative radiotherapy","2026-05-05",{"date":438,"type":37},"2026-05-12",{"date":440,"type":21},"2026-04-30",{"date":442,"type":21},"2029-04-30",{"name":43,"class":44},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":454,"conditions":455,"keywords":459,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":45},"100636887","thymic-disease-autoimmunity-and-neuromuscular-junction-integrity-in-myasthenia-gravis-100636887","NCT07571525","Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis","Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis: An Observational Prospective Translational Cohort Study","TAILOR-MG","Inclusion Criteria:\n\n* Age ≥18 years at the time of informed consent\n* Ability to provide written informed consent and comply with study procedures\n* Availability of a serum sample for testing MG-related antibodies\n* Availability of chest imaging (CT and\u002For MRI) to classify thymic status\n\nParticipants must also meet the criteria for at least one of the following study groups:\n\nCohort 1: Thymoma with MG-related antibodies\n\n* Histologically or radiologically confirmed thymoma\n* Presence of at least one pathogenic MG-related antibody (AChR)\n* Presence or absence of clinically manifest myasthenia gravis\n\nCohort 2: Other thymic abnormalities with MG-related antibodies\n\n* Imaging or histological evidence of non-thymomatous thymic pathology (e.g., thymic hyperplasia)\n* Presence of at least one pathogenic MG-related antibody (AChR)\n* Presence or absence of clinically manifest myasthenia gravis\n\nCohort 3: Thymoma without MG-related antibodies\n\n* Histologically or radiologically confirmed thymoma\n* Negative for pathogenic MG-related antibodies (AChR)\n* No clinical diagnosis or symptoms suggestive of myasthenia gravis\n\nCohort 4: Myasthenia gravis without thymic abnormalities\n\n* Established clinical diagnosis of myasthenia gravis with consistent clinical features, supported by at least one of the following:\n\n  1. Seropositivity for MG-related antibodies (AChR, MuSK, or LRP4), or\n  2. Abnormal neuromuscular transmission demonstrated by SFEMG or RNS, or\n  3. Improvement of MG signs with treatment such as oral acetylcholinesterase inhibitors, plasma exchange, IVIg, or corticosteroids\n* Absence of thymic abnormalities on CT or MRI\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Other neuromuscular diseases that could interfere with interpretation of clinical or neurophysiological findings\n* Severe uncontrolled systemic illness that, in the investigator's judgment, may limit participation or confound study outcomes\n* Any medical or psychiatric condition, or history of substance abuse, that may compromise adherence to study procedures\n* Pregnancy or breastfeeding",{"count":453,"type":21},40,"The goal of this observational study is to investigate the clinical, immunological, and neuromuscular features associated with the development and progression of myasthenia gravis (MG) in adult patients with thymic abnormalities and\u002For MG-related antibodies, including individuals with or without clinically manifest disease.\n\nThe main questions it aims to answer are:\n\n* Whether integrated clinical, serological, and histopathological profiles are associated with the presence of MG and can predict disease onset or progression\n* Wheter systemic immune markers are associated with disease activity, progression, and neuromuscular junction alterations\n\nParticipants will:\n\n* Undergo clinical, neurological, and neurophysiological assessments at baseline and during follow-up\n* Provide blood samples for serological and immunological analyses\n* Provide thymic tissue and residual intercostal muscle samples (when undergoing clinically indicated thymectomy) for research analyses\n* Attend follow-up visits at 6, 12, and 18 months\n* Record daily symptoms using an electronic patient-reported outcome tool (for participants with MG)",[456,457,458],"Myasthenia Gravis (MG)","Myasthenia Gravis Associated With Thymoma","Thymoma",[460,461],"myasthenia gravis","thymoma",{"date":414,"type":37},{"date":464,"type":21},"2026-09-15",{"date":466,"type":21},"2029-12-01",{"name":43,"class":44},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":475,"targetDuration":477,"studyType":58,"phases":4,"briefSummary":478,"conditions":479,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":494},"100634791","spectral-and-ultra-high-resolution-ct-systems-for-non-invasive-detection-of-myocardial-ischemia-stress-ct-perfusion-vs-ffr-ct-100634791","NCT07544277","Spectral and Ultra High Resolution CT Systems for Non-Invasive Detection of Myocardial Ischemia: Stress CT Perfusion VS. FFR-CT","SURE-CT","Inclusion Criteria:\n\n* Patient referred to our hospitals for elective CCTA for ruling out CAD\n* CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines\n\nExclusion Criteria:\n\n* hemodynamically unstable conditions,\n* previous revascularization,\n* myocardial infarction,\n* obesity (BMI\\>40 kg\u002Fm2),\n* renal insufficiency (GFR\\\u003C30 mL\u002Fmin),\n* atrial fibrillation or other significant arrhythmias; and\n* other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),\n* pregnancy and breastfeeding,\n* contraindications to iodinated contrast agents or regadenoson.",{"count":476,"type":21},142,"24 Months","Coronary artery disease (CAD) is the leading cause of mortality and morbidity worldwide. Coronary Computed Tomography angiography (CCTA) gained a pivotal clinical role for excellent sensitivity in rule-out CAD, but has limited specificity for a tendency to overestimate stenoses and for the lack of information about their hemodynamic impact. Fractional Flow Reserve derived from CT (FFR-CT) and stress CT perfusion (CTP) have been recently proposed to complement CCTA in the non-invasive assessment of myocardial ischemia, increasing the specificity and avoiding unnecessary catheterization. However, on energy-integrating (EID)-CT, FFR-CT has suboptimal performance, while CTP is affected by high radiation exposure. Both these approaches may benefit by the introduction of the new Photon Counting Detector (PCD)-CT technology, but data completely lacks. Aim of the study is to assess the performance of PCD-CT in the identification of significant CAD combining CCTA with FFR-CT and spectral CTP.",[480,481,482,483],"FFR-CT","CT Angiography","CT Perfusion","Coronary Arterial Disease (CAD)",[480,485,482,483],"Coronary CT angiography","2026-04-15",{"date":488,"type":37},"2026-04-22",{"date":490,"type":21},"2026-09-01",{"date":492,"type":21},"2029-09-01",{"name":43,"class":44},2,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":503,"targetDuration":262,"studyType":58,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":514,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":45},"100548211","infectious-disease-registry-biobank-100548211","NCT06418048","INfectious DIsease REgistry BIObank","Prospective Registry and Biobank of Patients With Infectious Diseases","INDI-REBIO","Inclusion Criteria:\n\n* Patients with clinically suspected or microbiologically documented infectious diseases (bacterial, viral, fungal or parasitic);\n* At least 18 years of age or older;\n* Able to provide informed consent;\n* Participants who are unable to understand the study protocol or are unable to give informed consent, but have a legal representative\n\nExclusion Criteria:\n\n\\- Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative.",{"count":504,"type":21},10000,"Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank.",[507,508,509,510,511,512,513],"Bloodstream Infections","Central Nervous System Infections","Bone and Joint Infections","Endovascular Infections","Infective Endocarditis","CIED-related Infections","Vertebral Osteomyelitis","RECRUITING",{"date":516,"type":37},"2026-04-20",{"date":518,"type":37},"2024-02-01",{"date":520,"type":21},"2044-07-31",{"name":43,"class":44},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":529,"targetDuration":531,"studyType":58,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":45},"100633408","anticipating-irreversible-disability-in-neuromyelitis-optica-spectrum-disorder-a-study-to-assess-disease-activity-in-apparently-stable-patients-100633408","NCT07526298","Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Apparently Stable Patients","Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Multicenter Prospective Observational Study to Assess Disease Activity in Apparently Stable Patients","Inclusion Criteria:\n\n* Adult patients (age ≥18 years);\n* NMOSD diagnosis with AQP4 IgG positive status assessed with a cell-based assay;\n* Under rituximab treatment (standard of care) from at least 1 year and for not more than 5 years;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* History of a clinical relapse or new\u002Fenlarging T2 lesion during the 6 months preceding the enrollment;\n* Steroids treatment during 30 days before the enrollment;\n* Any contraindication to MRI;\n* Patients currently participating in a different clinical trial;\n* Patients currently pregnant.",{"count":530,"type":21},50,"12 Months","The present research is an observational clinical study. The project aims to investigate astrocytic damage, assessed through biological findings such as an increase in GFAP level and\u002For MRI water index, in patients with NMOSD and its potential role in predicting demyelinating relapses or affecting disability outcomes. It will also explore predictors of astrocytic relapses, focusing on demographic, clinical, and immunological biomarkers like T cell responses, B cell repopulation, and cytokine levels. The goal is to identify unrecognized disease activity, providing insights for future research and clinical trials.\n\nThe study will involve 8 sites in Italy: 6 NMOSD clinical centers for patient enrolment and 2 centers for bioengineering and biological analysis. Centralized analysis of the MRI images of all patients enrolled in the clinical centers will be performed by the Neuroimaging Research Unit Fase 1 of San Raffaele Hospital. A total of 50 patients will be included and they will be followed for 12 months.\n\nComprehensive evaluation of patients, including clinical assessment, bioengineering evaluation, MRI, and blood samples, will be conducted at baseline, month 6, and month 12. To assess silent astrocytic relapses, a specialized evaluation will take place at months 3 and 9, including clinical analysis, blood samples to assess biomarkers like GFAP, a reduced MRI protocol to assess MRI water index, and bioengineering evaluation. In the case of a classical relapse, a dedicated visit will occur within 5 days of symptom onset, using the same evaluation protocol as at months 3 and 9 (MRI and biomarkers will be evaluated if not done in the month before).",[534],"Neuromyelitis Optica Spectrum Disorders",[536,537,63,538],"Relapse","Astrocytic damage","GFAP","2026-04-10",{"date":541,"type":37},"2026-04-13",{"date":543,"type":21},"2026-04-01",{"date":545,"type":21},"2027-04-01",{"name":43,"class":44},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":346,"minAge":553,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":514,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":45},"100550643","a-prospective-observational-study-of-artificial-intelligence-morphometric-evaluation-of-vertebral-fractures-100550643","NCT06449742","A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures","Inclusion Criteria:\n\n1. Male subjects\n2. Age ≥ 50 years\n3. Clinical and medical history data available at abdomen-chest CT evaluation\n4. Signature of informed consent to the study\n\nExclusion Criteria:\n\n1. Hospitalized patients\n2. Patients known to have osteo-metabolic diseases.\n3. with primary and\u002For acquired immunodeficiency states, and\u002For severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening\u002Freacute\u002Fcompensated chronic diseases; moderate-severe renal failure)\n4. Patients unable to understand and sign the Informed Consent.","50 Years",{"count":555,"type":21},250,"The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.",[558,559],"Vertebral Fracture","Osteoporosis","2026-04-02",{"date":562,"type":37},"2026-04-08",{"date":564,"type":37},"2025-03-01",{"date":566,"type":21},"2027-03-01",{"name":43,"class":44},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":514,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":45},"100553055","prospective-monocentric-registry-of-patients-undergoing-vitamin-d-treatment-at-san-raffaele-hospital-100553055","NCT06481111","Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital","Inclusion Criteria:\n\n* Adult men and women (age ≥ 18 years) regardless of fertility status and pregnancy\u002Fbreastfeeding conditions\n* Vitamin D supplementation, with any formulation and dosage\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Patients unable to understand and sign informed consent.",{"count":575,"type":21},1000,"The Endocrinology Unit of the IRCCS San Raffaele Hospital is dedicated to establishing a prospective single-center registry with data from patients undergoing vitamin D supplementation, initiating their first visit to the outpatient unit until December 2029. 1000 patients will be enrolled, aligning with the unit's recent patient influx for hypovitaminosis D.\n\nThe registry's goal is to assess the epidemiological trend, identify risk factors, and evaluate the diagnostic and therapeutic clinical management strategies for hypovitaminosis D. It will involve collecting clinical, laboratory, and historical data during outpatient visits, adhering to the standard diagnostic and therapeutic protocols for endocrine-metabolic diseases. This data collection is expected to continue for a duration of ten years.",[578],"Hypovitaminosis D",{"date":562,"type":37},{"date":581,"type":37},"2024-07-10",{"date":583,"type":21},"2034-12-01",{"name":43,"class":44},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":593,"targetDuration":594,"studyType":58,"phases":4,"briefSummary":595,"conditions":596,"keywords":600,"overallStatus":514,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":45},"100632775","genetic-and-biohumoral-factors-involved-in-menires-disease-and-their-correlation-with-phenotypes-100632775","NCT07518069","Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes","Genetics and Biohumoral Factors in Menière's Disease","Menière09","Inclusion Criteria:\n\n* Patients with definite Menière's Disease according to the criteria of the Barany Society\n\nExclusion Criteria:\n\n* surgically treated before the examination or if they had undergone intratympanic therapy with steroids or gentamicin",{"count":555,"type":21},"6 Months","Aim of this work was to assess the role of polymorphisms belonging to genes involved in the regulation of ionic homeostasis in Caucasian patients with Ménière Disease (MD) and compare results with a cohort of patients affected by vestibular migraine and a cohort of non vestibular subjects",[597,598,599],"Vertigo","Meniere's Disease","Vestibular Migraine",[601,602,603,604,605],"episodic vertigo","Menière's Disease","Vestibular migraine","genetics","biohumoral markers",{"date":562,"type":37},{"date":608,"type":37},"2025-04-09",{"date":610,"type":21},"2027-04-12",{"name":43,"class":44},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":622,"conditions":623,"keywords":628,"overallStatus":514,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":45},"100410278","advanced-therapies-for-liver-metastases-100410278","NCT04622423","Advanced Therapies for Liver Metastases","Advanced Immune Gene and Cell Therapies for Liver Metastases","LiMeT","Inclusion and exclusion criteria - CRC patients\n\nInclusion criteria:\n\n1. Patients with histologically or cytologically confirmed diagnosis of CRC metastatic to the liver (stage IV disease, AJCC)\n2. Patients with indication to surgical resection and\u002For chemotherapy treatment\n3. Age ≥18\n4. ECOG PS 0-1 at enrollment\n5. Written informed consent\n6. Patients will be treated in IRCCS San Raffaele\n\nExclusion criteria:\n\n1. Pregnancy or lactation\n2. Inability to provide a written informed consent\n3. Extraepatic disease with the exception of selected cases in which the coexistence of extrahepatic disease does not constitute an exclusion criterion for hepatic resective surgery (for example in patients with extraepatic lesions in remission or in any case stabilized by chemotherapy)\n4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities, HIV, autoimmune disorders)\n5. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy\n6. Other conditions (medical or psychiatric) that in the judgment of Investigators would make the patient an inappropriate candidate for the study\n\nInclusion and exclusion criteria - PDAC patients\n\nInclusion criteria:\n\n1. Patients with clinical\u002Fradiological diagnosis\u002Fsuspicious of pancreatic adenocarcinoma metastatic to the liver, with subsequent cytological\u002Fhistological confirmation (stage IV disease, AJCC)\n2. Age ≥18\n3. Karnofsky performance status ≥50\n4. Metastatic pancreatic adenocarcinoma patients with histological specimens from whole liver metastasis biopsy or core liver biopsy collected at IRCCS San Raffaele and stored in the institutional biobank Centro Risorse Biologiche (CRB-OSR)\n5. Written Informed consent\n6. Patients with clinical\u002Fradiological diagnosis of not metastatic primary PDAC that will undergo pancreatic resection at IRCCS San Raffaele\n\nExclusion criteria:\n\n1. Severe comorbidities (e.g., cardiac diseases, history of psychiatric disabilities) representing an absolute contraindication for whole or core liver metastasis biopsy\n2. Pregnancy or lactation\n3. Inability to provide a written informed consent\n4. Metastatic pancreatic adenocarcinoma patients enrolled in other research trials entailing the analysis of the liver metastasis histological sample",{"count":621,"type":21},625,"Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies.\n\nBased on preliminary and published data, the investigators hypothesize that innovative immune, gene, and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC.\n\nThe investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, preneoplastic, metastatic, and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and\u002For liver metastases as well as correlate changes in the activation status and phenotype of peripheral blood leukocytes. Healthy volunteers will be enrolled as negative controls.\n\nThe investigators aim at identifying: i) actionable tumor-associated antigens (TAAs) and local immune suppressive and regulatory pathways; ii) biological parameters for early diagnosis of relapse; iii) the effect of therapies on the shaping of anti-tumor immune responses.\n\nData collected will be instrumental for the generation of novel advanced therapy medicinal products (ATMPs). Indeed, this protocol is part of a multi-partner translational program, supported by the AIRC 5 per Mille 2019 grant, focused on the development, validation, and implementation of clinical testing for ATMPs to ameliorate the cure of CRC and PDAC, and possibly to help the study of other solid tumors.\n\nMoreover, the systematic and long-term follow-up of enrolled patients will possibly point to early predictors of differential prognosis and patients' categories eligible for tailored therapies, including those with the novel ATMPs.\n\nIn this regard, two additional substudies were incorporated into the main LiMeT protocol in July 2024 and January 2026, respectively, supported by supplementary funding: 1) the TREATLIVMETS (Treating Liver Metastasis) project, funded by the European Research Council (ERC) under the Horizon Europe research and innovation program; 2) the \"Deciphering and targeting the immunological niche in PDAC\" project, funded by the Fondazione Regionale per la Ricerca Biomedica (FRRB) under the \"From Bed to Bench 2024\" call. In the latter substudy, machine learning will be integrated with the spatial multi-omic profiling of the immune landscape in preneoplastic and neoplastic lesions in a subset of IPMN and PDAC patients, supporting the discovery of new therapeutic targets and enabling the early detection of preneoplastic lesion progression.",[624,625,626,627],"Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","Liver Metastasis","IPMN, Pancreatic",[629,630,631,632,633,634,635,636,637,638,639,640,641,642],"Pancreatic ductal adenocarcinoma","Colorectal cancer","PDAC","CRC","Liver metastases","Tumor microenvironment","Immunosuppression","Immune therapy","Cell therapy","Gene therapy","Tumor infiltrating lymphocytes","ATMP","Intraductal Papillary Mucinous Neoplasms","IPMN","2026-03-31",{"date":645,"type":37},"2026-04-06",{"date":647,"type":37},"2019-11-06",{"date":649,"type":21},"2030-06-30",{"name":43,"class":44},""]