[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pelvic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pelvic-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,73,102,130,154,181,205,229,262],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100633166","assessment-of-sexual-quality-of-life-following-local-treatment-radiotherapy-with-or-without-surgery-in-patients-with-hpv-positive-pelvic-cancer-a-descriptive-longitudinal-study-100633166",false,"NCT07523152","Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study","SAPPHIRE","Inclusion Criteria:\n\n1. Women aged 18 or over.\n2. Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.\n3. Patients being treated at the Montpellier Cancer Institute (ICM).\n4. Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection\n5. Patient aware of her HPV status and how it is transmitted.\n6. Indicated for external radiotherapy\n7. Patient who has not received any oncological treatment prior to inclusion.\n8. Patient who has given verbal consent.\n\nExclusion Criteria:\n\n1. Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).\n2. Patients who are unwilling or unable to complete the study questionnaires.\n3. Patients under guardianship, curatorship or court protection,\n4. Patients for whom regular follow-up is impossible for psychological reasons,\n5. Patients who do not speak French.","FEMALE","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"NA","In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.\n\nHowever, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery\u002Fquality of sexuality following radiotherapy.\n\nIt is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.\n\nThis type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.",[26,27,28],"Pelvic Cancer","Anal Cancer","Vaginal Cancer",[30,31,32],"vaginal cancer","uterus cancer","anal canal cancer","NOT_YET_RECRUITING","2026-04-04",{"date":36,"type":37},"2026-04-13","ACTUAL",{"date":39,"type":20},"2026-04-02",{"date":41,"type":20},"2027-10-31",{"name":43,"class":44},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100094723","a-study-to-determine-whether-perioperative-energy-dynamics-correlates-with-postoperative-outcomes-100094723","NCT00493688","A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes","Inclusion Criteria:\n\n* Participants 18 years of age or older.\n* Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and\u002For immunotherapy.\n* Participants who have signed the consent form to participate in the study.\n* Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist.\n* All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center.\n* No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation.\n\nExclusion Criteria:\n\n* Participant is under age 18.\n* Participant is unwilling to sign consent.\n* Participant is unable to exercise (bedridden or wheel chair bound).\n* Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.\n* Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.\n* Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina.\n* Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation.\n* Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation.\n* Participant is known to have acute or chronic deep vein thrombosis.\n* Participant is pregnant.","ALL",{"count":53,"type":20},200,"OBSERVATIONAL","To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.\n\nIn this proposed study researchers will:\n\n1. Measure preoperative energy reserve capacity (fitness)\n2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism",[57,26],"Abdominal Cancer",[57,26,59,60,61],"Perioperative Energy Dynamics","Cardiopulmonary Exercise Testing","CPET","RECRUITING","2026-01-06",{"date":65,"type":37},"2026-01-08",{"date":67,"type":37},"2005-10-30",{"date":69,"type":20},"2028-10-30",{"name":71,"class":44},"M.D. Anderson Cancer Center",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":72},"100609582","vaginal-dilator-therapy-after-pelvic-radiation-100609582","NCT07216456","Vaginal Dilator Therapy After Pelvic Radiation","Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* female sex\n* adults aged 18 years or older\n* diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and\u002For bladder\n* completed pelvic radiation therapy in the past year\n* dilator therapy recommended by medical provider and standardized dilator received from provider\n* able to speak\u002Fread English\n\nExclusion Criteria:\n\n* aged less than 17 years\n* under the care of a pelvic floor physical therapist at the time of study enrollment\n* have a major\u002Fserious psychiatric concern (e.g., schizophrenia) as indicated by medical chart\u002Fmedical provider\n* inability to provide consent",{"count":81,"type":20},88,[23],"This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed.\n\nIn this study, 88 participants will be randomly assigned to one of two groups:\n\n* One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use.\n* The other group will receive written educational materials (enhanced usual care).\n\nThe study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins.\n\nThe goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.",[85,86,26,87,88,89],"Pelvic Radiotherapy","Vaginal Stenosis","Gynecologic Cancers","Anorectal Cancer","Urologic Cancer",[91,92],"vaginal dilator therapy","pelvic radiation","2025-10-13",{"date":95,"type":37},"2025-10-15",{"date":97,"type":20},"2027-08-01",{"date":99,"type":20},"2030-04-30",{"name":101,"class":44},"Duke University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":51,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100564863","scintix-bgrt-using-rmrs-in-solid-and-soft-tissue-tumors-100564863","NCT06634706","SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors","Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System in in a Variety of Solid and Soft Tissue Tumors (BIOGUIDE-X2)","Inclusion Criteria:\n\n1. Age greater than 21 years.\n2. A new or prior diagnosis of biopsy-proven cancer.\n3. At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).\n4. Target tumor size ≥2cm and ≤5cm.\n5. Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:\n\n   1. SUVmax≥6, as assessed on diagnostic PET\u002FCT performed within 60 days of enrollment with no new intervening oncologic therapies.\n   2. Ratio of target tumor SUVmax to SUVmean of local background region (defined as a 3 mm shell 1.5 cm from the target tumor) is greater than 6, as assessed on diagnostic PET\u002FCT performed within 60 days of enrollment with no new intervening oncologic therapies.\n6. ECOG Performance Status 0-3.\n7. Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active lesion that is unresponsive to ongoing systemic therapy.\n8. Females of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to initiation of study scans.\n\nExclusion Criteria:\n\n1. Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET\u002FCT scan.\n2. Lung parenchymal and bone target tumors\n3. At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:\n\n   1. 3 cm from target on diagnostic PET\u002FCT in directions where limited target motion is expected\n   2. 4 cm from target on diagnostic PET\u002FCT in directions where sizable target motion is expected\n4. Known allergy to FDG.\n5. Known psychiatric or substance abuse disorder that would interfere with conduct of the study.\n6. Pregnant, breast-feeding or expecting to conceive during the study.\n7. Patient weight exceeding the weight limit outlined per user manual.\n8. Patients with pacemakers and other implantable devices deemed at high risk by the treating physician for complications secondary to radiotherapy, according to institutional guidelines and published guidelines (e.g. AAPM task group-203).\n9. Active inflammatory bowel disease, scleroderma, or other disorder deemed by the treating physician to put the patient at risk for excess toxicity in the setting of external beam radiation therapy (EBRT) or FDG injection.","21 Years",{"count":111,"type":20},96,[23],"This study proposes 6 anatomic groupings which each can be defined similarly as the \"head and neck\" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the \"emulated\" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category (\"Distributed or orphan\") is meant to capture tumor types that can manifest across anatomies and\u002For for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.",[115,116,26,117,118,119],"Thoracic Cancer","Head and Neck Cancer","Hepatobiliary Carcinoma in Situ","Retroperitoneal Cancer","Distributed and Orphan Tumors","2025-08-12",{"date":122,"type":37},"2025-08-13",{"date":124,"type":20},"2025-12-01",{"date":126,"type":20},"2027-01-01",{"name":128,"class":129},"RefleXion Medical","INDUSTRY",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100602900","health-oriented-protocol-for-epidermal-radiodermatitis-100602900","NCT07129525","Health Oriented Protocol for Epidermal Radiodermatitis","Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study","HOPE","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* with head and neck or pelvic malignancies\n* undergoing either exclusive radiotherapy or concurrent chemoradiotherapy will be included, following signed informed consent.\n\nExclusion Criteria:\n\n* Pediatric patients,\n* patients with malignancies outside the head and neck or pelvic regions,\n* patients who have not yet started or have already completed exclusive radiotherapy or concurrent chemoradiotherapy",{"count":139,"type":20},80,"Radiation therapy is a standard treatment for malignant tumors of the head and neck and pelvic regions, used alone or in combination with chemotherapy. While effective, it is often associated with adverse effects that can impact patient outcomes. Among the most frequent toxicities is radiation-induced dermatitis (RID), affecting up to 95% of patients. These skin reactions, ranging in severity, may compromise quality of life and lead to treatment interruptions.The severity of RID is influenced by both intrinsic and extrinsic factors. Intrinsic factors include age, sex, ethnicity, nutritional status, and comorbidities such as diabetes or systemic inflammation. Extrinsic factors include the radiation technique, total dose, treated volume, and presence of infections. These variables require close monitoring to reduce complications.Radiation damages the skin and underlying tissues, causing xerosis, pigmentation changes, loss of elasticity, fibrosis, and varying degrees of dermatitis. Effective prevention starts with patient education and skincare support throughout treatment to reduce incidence and severity.In Italy, head and neck cancers, though less common than other malignancies, present a significant clinical burden. Laryngeal cancer accounts for around 5,000 new cases annually. Oral cavity, pharyngeal, and thyroid tumors also have notable incidence and require complex treatments such as (chemo)radiotherapy, increasing the risk of RID.RID represents not only a clinical issue but also a psychological and functional challenge. Pain, emotional distress, and reduced autonomy are key aspects affecting patients' overall wellbeing. A multidimensional approach that integrates clinical care and psychosocial support is essential.This study aims to investigate the relationship between RID severity, pain, psychological distress, and functional autonomy during radiotherapy or chemoradiotherapy, identifying predictors of severe toxicity and guiding personalized supportive care.",[116,26,142,143,144],"Radiation Skin Injury","Gynecologic Cancer","Radiotherapy Side Effect","2025-08-11",{"date":147,"type":37},"2025-08-19",{"date":149,"type":20},"2025-09",{"date":151,"type":20},"2026-09-30",{"name":153,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":72},"100489064","feasibility-of-hyivy-device-post-radiation-for-pelvic-malignancies-100489064","NCT05648253","Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies","Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies","Inclusion Criteria:\n\n* 1.Age ≥ 18 at the time of enrollment\n* 2.Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy\n* 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)\n* 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2\n* 5.Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and\u002For uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.\n* 6.Agree not to use other dilators for the 12-week intervention period\n* 7.Must have the ability to charge the investigational device\n* 8.Must be willing and able to insert intravaginal device\n* 9.Able to understand, comply and consent to protocol requirements and instructions\n* 10.Able to attend scheduled study visits and complete required investigations\n* 11.Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* 1.Participants who are pregnant or planning to become pregnant during the trial\n* 2.Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study\n* 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)\n* 4.Allergy to Hyivy device's materials\n* 5.Active pelvic or gynaecological infection\n* 6.Current use of antibiotics for any infection\n* 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area\n* 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina\u002Fvaginal area, at the discretion of the investigator(s)\n* 9.Hypoesthesia or loss in sensation of the pelvic floor\n* 10.Total and\u002For partial prolapse of the uterus and\u002For vagina\n* 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence\n* 12.Unable to position the device according to directions for use\n* 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants",{"count":162,"type":20},12,[23],"Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.",[86,166,167,168,26],"Radiation Therapy","Cancer","Pelvic Pain",[170,171],"Dilator","Post radiation therapy","2025-04-17",{"date":174,"type":37},"2025-04-22",{"date":176,"type":37},"2025-04-11",{"date":178,"type":20},"2026-06",{"name":180,"class":129},"Hyivy Health Inc",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100456090","reconstruction-in-extended-margin-cancer-surgery-100456090","NCT05219058","Reconstruction in Extended MArgin Cancer Surgery","REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study","REMACS","Inclusion Criteria:\n\n* Male and female patients aged 18 or older\n* Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)\n* Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)\n* Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)\n\nExclusion Criteria:\n\n* Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery\n* Patients that undergo surgery by an intersphincteric abdominoperineal resection approach\n* Patients that are unable to complete the questionnaire over the telephone or online with a researcher\n* Patients unable or unwilling to provide informed consent\n* Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service",{"count":190,"type":20},236,"Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect.\n\nReconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes.\n\nREMACS has three work packages:\n\n1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures.\n2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity.\n3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries.\n\nThe last two work packages have now been funded by an NIHR Research for Patient Benefit Grant",[193,26,57,194],"Surgery--Complications","Quality of Life","2025-01-29",{"date":197,"type":37},"2025-01-31",{"date":199,"type":37},"2022-05-17",{"date":201,"type":20},"2028-01-01",{"name":203,"class":44},"University Hospital Southampton NHS Foundation Trust",18,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":72},"100556444","ai-as-an-aid-for-weekly-symptom-intake-in-radiotherapy-100556444","NCT06525181","AI as an Aid for Weekly Symptom Intake in Radiotherapy","Evaluation of AI-Enhanced Symptom Summarization in Weekly Radiotherapy Consultations: A Comparative Study","Inclusion Criteria:\n\nAll patients undergoing radiotherapy in the pelvic region.\n\nExclusion Criteria:\n\nCases of pelvic reirradiation or operated cases.",{"count":53,"type":20},[23],"The study investigates the use of artificial intelligence (AI) and large language models (LLMs) to enhance the efficiency and accuracy of weekly treatment consultations (OTVs) in radiotherapy. It hypothesizes that an AI-enabled symptom summary tool will match traditional medical review methods in accuracy while saving time. The study includes patients undergoing pelvic radiotherapy and excludes those with pelvic reirradiation or who have undergone surgery. Patients will receive both standard and AI-assisted weekly consultations, with AI summaries generated using the OpenAI GPT-4 API. Blinded oncologists will compare the accuracy and quality of the AI-generated and doctor-generated summaries, while patients and doctors will rate these summaries. The primary objective is to evaluate the accuracy and time efficiency of AI-assisted symptom summaries compared to traditional methods.",[144,26,216],"Patient",[218,219],"Artificial Intelligence","Patient-Reported Outcome","2024-10-08",{"date":222,"type":37},"2024-10-10",{"date":224,"type":37},"2024-07-22",{"date":226,"type":20},"2024-12-15",{"name":228,"class":129},"jaide",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":236,"conditions":237,"keywords":246,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100486163","ultrasound-guided-tru-cut-biopsy-in-pelvic-masses-100486163","NCT05610501","Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.","Inclusion Criteria:\n\n* 1\\. Following lesion criteria applicable for biopsy:\n\n  1. Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)\n  2. Solid component present (purely cystic lesions excluded)\n\n     2\\. Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.\n\n     3\\. In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:\n\n  \u003C!-- -->\n\n  1. Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and\n\n     * Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing\n     * Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and\u002For diagnostic laparoscopy\n  2. Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)\n  3. Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.\n  4. Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.\n  5. Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.\n\nExclusion Criteria:\n\n\\- 1. Patients \\\u003C 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.\n\n3\\. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment",{"count":53,"type":20},"In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.\n\nThis clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.",[26,238,239,240,241,242,243,244,245],"Ovarian Cancer","Cervical Cancer","Uterus Cancer","Endometrial Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Sarcoma Uterus","Metastatic Cancer",[247,248,249,250,251],"Tru-cut","Ultrasound","Pelvic mass","Ovarian cancer","Gynaecologic oncology","2024-07-01",{"date":254,"type":37},"2024-07-03",{"date":256,"type":37},"2021-05-01",{"date":258,"type":20},"2025-04-30",{"name":260,"class":44},"Universitaire Ziekenhuizen KU Leuven",4,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":268,"targetDuration":270,"studyType":54,"phases":4,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":72},"100492734","advanced-pelvic-surgical-oncology-database---prospective-observational-study-100492734","NCT05696002","Advanced Pelvic Surgical Oncology Database - Prospective Observational Study","Inclusion Criteria:\n\n* Advanced pelvic oncological resection defined as more than 1 pelvic organ resected\n\nExclusion Criteria:\n\n\\-",{"count":269,"type":20},300,"10 Years","Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy\u002Fflap reconstruction\u002Furinary reconstruction at Glasgow Royal Infirmary.\n\nGoal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.",[273,26,143,274],"Rectal Cancer","Colon Cancer",[276,277,278,279],"Pelvic exenteration","Abdominoperineal resection","Reconstructive flap","Rectal cancer","2023-01-13",{"date":282,"type":37},"2023-01-25",{"date":284,"type":37},"2023-01-14",{"date":286,"type":20},"2030-01-01",{"name":288,"class":44},"Glasgow Royal Infirmary"]