[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05568420":3,"trial-entities:NCT05568420":75,"trial-summary:NCT05568420":79},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":36,"healthy_volunteers":37,"eligibility_criteria":38,"std_ages":56,"locations":58,"central_contacts":66,"overall_officials":67,"references":71,"see_also_links":72},"NCT05568420","22-254","A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)","Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer","ACTIVE_NOT_RECRUITING","2027-09","2026-08","2026-08-20","2022-09-30","Memorial Sloan Kettering Cancer Center","OTHER",null,"This study will collect biospecimens (including blood, tissue, and stool samples) and health information to create a database-a type of collection of information-for better understanding young onset colorectal cancer (YOCRC). The study will include both people with YOCRC and healthy people.",[18],"Colorectal Cancer",[20,21,5],"Pharmacologic","Colectomy specimens","OBSERVATIONAL",[],{"count":25,"type":26},41,"ACTUAL",[],[29],{"measure":30,"description":31,"timeFrame":32},"genomic analysis of tissue","For the genomic analyses, we will perform whole exome sequencing, MSK-IMPACT DNA-methylation and RNA assays of normal colonic mucosa and tumor. Other genomic analysis may be performed depending on the results of the initial analysis developments in this field. We will compare normal mucosa plus tumor in YOCRC vs normal mucosa in controls (using biopsies collected during outpatient colonoscopies not associated with hospitalizations)","3 years",[],"ALL","18 Years","49 Years",true,{"inclusion":39,"exclusion":47,"raw_text":55},[40,41,42,43,44,45,46],"18-49 years old","Histological or cytological diagnosis of colorectal adenocarcinoma","Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and\u002For have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample)","Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, PI)","18-49 years old at time of diagnosis","Scheduled for standard-of-care colonoscopy at MSK","Underwent surgical resection of a traumatic injury to the colon at Shaare Zedek Medical Center (SZMC)",[48,49,50,51,52,53,54],"CRC Cohort:","Antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample)","Known inherited cancer susceptibility gene","History of inflammatory bowel disease","Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)","History of or prior treatment for cancer ≤ 5 years prior to registration. Exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.","Colonoscopy for indications of IBD, anemia and\u002For genetic predisposition (only patients providing tissue sample).","Inclusion Criteria:\n\nCRC Cohort:\n\n* 18-49 years old\n* Histological or cytological diagnosis of colorectal adenocarcinoma\n* Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and\u002For have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample)\n* Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, PI)\n\nHealthy Control Cohort:\n\n* 18-49 years old at time of diagnosis\n* Scheduled for standard-of-care colonoscopy at MSK\n* Underwent surgical resection of a traumatic injury to the colon at Shaare Zedek Medical Center (SZMC)\n\nExclusion Criteria:\n\n* CRC Cohort:\n* Antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample)\n* Known inherited cancer susceptibility gene\n* History of inflammatory bowel disease\n\nHealthy Control Cohort:\n\n* Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)\n* History of or prior treatment for cancer ≤ 5 years prior to registration. Exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.\n* Colonoscopy for indications of IBD, anemia and\u002For genetic predisposition (only patients providing tissue sample).",[57],"ADULT",[59],{"facility":13,"city":60,"state":60,"zip":61,"country":62,"geoPoint":63},"New York","10065","United States",{"lat":64,"lon":65},40.71427,-74.00597,[],[68],{"name":69,"affiliation":13,"role":70},"Andrea Cercek, MD","PRINCIPAL_INVESTIGATOR",[],[73],{"label":13,"url":74},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":76,"biomarkers":78},[77],"Colorectal Carcinoma",[],{"nct_id":4,"found":37,"summary":80,"prompt_version":90},{"design":81,"status":82,"heading":83,"summary":84,"follow_up":85,"word_count":86,"commitments":87,"compensation":88,"drugs_mentioned":89},"This is an observational study with a planned enrollment of 160 participants. It will include both individuals with colorectal cancer and healthy people.","completed","Understanding Young Onset Colorectal Cancer (YOCRC)","This study aims to better understand colorectal cancer that affects younger individuals (YOCRC). Researchers will collect blood, tissue, and stool samples, along with health information, from people with YOCRC and healthy individuals. This information will be used to create a database. The main goal is to analyze the genetic makeup of tissue samples over three years to learn more about this condition. You may be able to join if you are between 18 and 49 years old and have been diagnosed with colorectal adenocarcinoma. The current recruitment status is unclear.","Tissue samples will be analyzed at 3 years, which may indicate a follow-up period.",90,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]