[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983",false,"NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",true,"ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[26,27,28,29,30],"Gastric Cancer","Colorectal Cancer","Breast Cancer","Cervical Cancer","Head and Neck Cancer (H&N)",[32,33,34,35,36,37,38,39],"Microbiome","Cancer","Immunotherapy","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics","RECRUITING","2026-06-24",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2026-06-11",{"date":48,"type":22},"2029-08-30",{"name":50,"class":51},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100643034","vortioxetine-for-cognitive-function-in-alk-positive-nsclc-treated-with-lorlatinib-100643034","NCT07633626","Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib","Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ALK\u002FROS1-positive non-small cell lung cancer (NSCLC), stage IIIB\u002FIV.\n* Currently receiving lorlatinib as part of the standard therapeutic regimen.\n* Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.\n* Age \\>= 18 years.\n* ECOG performance status 0-2.\n* Ability to understand and sign informed consent.\n* Expected survival \\>= 6 months.\n* Planned initiation of vortioxetine as part of standard care.\n* Ability to complete neuropsychological tests and questionnaires in Spanish.\n\nExclusion Criteria:\n\n* Prior diagnosis of major cognitive impairment unrelated to cancer treatment.\n* Current use of another antidepressant that cannot be discontinued.\n* Uncontrolled major psychiatric disorder.\n* History of uncontrolled epilepsy or recent seizures.\n* Severe hepatic or renal impairment.\n* Known hypersensitivity to vortioxetine.\n* Participation in another clinical trial within the past 30 days.\n* Inability to provide informed consent.\n* Life expectancy \\\u003C 3 months.\n* Contraindications to vortioxetine (e.g., concomitant MAOI use).\n* Prior vortioxetine use.\n* Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.",{"count":61,"type":22},24,"This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.\n\nLorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.\n\nTwenty-four adult patients with ALK\u002FROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg\u002Fday) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.",[64,65,66,67,68,69],"Advanced ALK\u002FROS1-positive NSCLC","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Adenocarcinoma","ALK-positive Non-small Cell Lung Cancer (NSCLC)","Cognitive Dysfunction","Depression","2026-06-04",{"date":72,"type":44},"2026-06-08",{"date":74,"type":44},"2026-03-10",{"date":76,"type":22},"2027-11-10",{"name":50,"class":51},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":52},"100516013","study-to-evaluate-sbrt-for-egfr-mutant-nsclc-patients-receiving-osimertinib-cultro-100516013","NCT05998993","Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)","Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment","CULTRO","Inclusion Criteria:\n\n* Be older than 18 years of age.\n* Be capable of giving informed consent to participate in the study.\n* Have histological confirmation compatible with EGFR mutant non-small cell lung cancer (NSCLC) and metastatic disease (with or without histological confirmation of metastatic lesions).\n* Have confirmation of the presence of common EGFR mutations (exon 19 deletion, L858R\u002Fexon 21, or G719X) through any locally and internationally accepted standard tests.\n* Have received at least 12 weeks of Osimertinib treatment (with or without the addition of chemotherapy based on FLAURA2 study results after discussion with the investigative team).\n* Have a partial response defined by RECIST 1.1 criteria.\n* Have a maximum of 5 residual tumor lesions in up to 2 organs suitable for treatment with Stereotactic Ablative Radiotherapy (SABR).\n* Have the following imaging and clinical tests within 4 weeks before study entry:\n* Contrast-enhanced brain MRI.\n* Chest\u002Fabdomen\u002Fpelvis CT scan, with or without bone scan (at the investigator's discretion) if PET-CT was not performed.\n* 18-FDG PET-CT.\n* Spinal MRI for patients with vertebral or paravertebral metastases.\n* Electrocardiogram (EKG) and transthoracic echocardiogram.\n* Complete blood count and standard blood chemistry.\n* Negative pregnancy test for fertile women within 4 weeks prior to starting radiotherapy.\n* Liquid biopsy for assessment of tumor allelic fraction (baseline).\n* ECOG performance status 0-2.\n* All sites of oligoresidual disease must be safely treatable according to the following criteria:\n* All brain lesions must be treatable with SRS.\n* The maximum size for extracranial lesions will be up to 6 cm, with exceptions for bone metastases which may include lesions larger than 6 cm at the discretion of the investigative medical team (e.g., ribs, scapula, or pelvis).\n* Life expectancy \\>6 months.\n* Not eligible for surgical treatment.\n* Osimertinib treatment must be suspended 48 hours before the start of ablative therapy and cannot be initiated within 48 hours of receiving the last fraction. In patients receiving SBRT for central lung lesions, the suspension time for Osimertinib may be extended up to 5 days before and after ablative therapy.\n* Patients may have previously received treatments such as radiofrequency or microwave ablation for oligoresidual lesions, but imaging must demonstrate that the lesion persists and is treatable with SABR.\n* Metastatic tumor lesions that received initial treatment with radiosurgery cannot be included for SABR treatment.\n* If initial treatment was conventional radiotherapy, SABR could be considered if safe to administer. In this case, the ablative therapy must be discussed by the investigative team.\n* The eligibility and prognosis criteria will be reviewed by the multidisciplinary thoracic tumor board at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.\n\nExclusion Criteria:\n\n* Severe comorbidities contraindicating radiation therapy.\n* Bone metastases in the femur with a high risk of fracture.\n* Complete response to Osimertinib treatment (no oligoresidual disease for ablative treatment).\n* Inability to treat all oligoresidual lesions with ablative intent.\n* History of pneumonitis or functionally limiting interstitial lung disease. It may be considered limiting if the patient is unable to perform DLCO maneuvers or if adjusted DLCO is less than 35% of predicted, PaO2 at Bogotá altitude with FiO2 21% is less than or equal to 50 mmHg.\n* Clinical or radiological evidence of symptomatic spinal cord compression.\n* Dominant brain metastatic disease requiring surgical management (e.g., imminent herniation or hydrocephalus).\n* Candidate for a clinical trial with an experimental drug.\n* Inability to receive Osimertinib with minimal adherence.\n* Oligoresidual involvement in peritoneum, pleura, or bone marrow (non-measurable disease).\n* Leptomeningeal involvement (presumed based on imaging findings or confirmed by cerebrospinal fluid cytology).\n* Pregnant or breastfeeding women.","99 Years",{"count":88,"type":22},35,"INTERVENTIONAL",[91],"NA","Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and\u002For SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and secondary outcomes will include overall survival (OS), proportion of patients without progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an exploratory analysis will be conducted on the prognostic value of liquid biopsy (supplementary information), considering baseline presence of mutations (determined by Next Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).",[94,95,96,97,98],"EGF-R Positive Non-Small Cell Lung Cancer","Non Small Cell Lung Cancer","EGFR Exon 19 Deletion","EGFR Exon 21 Mutation","EGFR G719X","NOT_YET_RECRUITING","2023-08-16",{"date":102,"type":44},"2023-08-21",{"date":104,"type":22},"2023-11",{"date":106,"type":22},"2028-11",{"name":50,"class":51},""]