A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer

NCT04832763

Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 +10 more

ACTIVE_NOT_RECRUITING NA

Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers

NCT03563651

Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 +5 more

COMPLETED

Young-Onset Colorectal Cancer

NCT02863107

Colon Adenocarcinoma Colorectal Carcinoma Rectal Adenocarcinoma

ACTIVE_NOT_RECRUITING

Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer

NCT06568679

Early-onset Colorectal Cancer

RECRUITING

Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

NCT04205955

Rectal Carcinoma Rectosigmoid Carcinoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colorectal Cancer Cohort

* Stool collection prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.)
* Blood sample to be collected either prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.) or during surveillance.
* Prospective tissue collection will be utilized from clinically indicated diagnostic colonoscopies/biopsies/resections s, including surveillance colonoscopies. Non-diagnostically indicated tissue collections will not be performed. Some EOCRC patients will have already undergone prior surgical resection, with tissue (including normal colonic mucosae distant from the malignant tumor). The pathology FFPE blocks may be used as a source of normal colon tissue for genomic analysis.

No interventions assigned to this group

Healthy Control Cohort

Tissue collection of normal colon mucosa will be utilized from clinically indicated colonoscopies or from tissue obtained from a prior colonoscopy, non-diagnostically indicated tissue collections will not be performed. Colonoscopies for indications of IBD, anemia, and/or genetic predisposition will be excluded.

* Stool samples will be collected at time of colonoscopy. Samples to be collected either within 3-14 days before or at least 14 days after colonoscopy, to avoid changes in microbiome caused by colonoscopy prep.
* Blood samples will be collected at time of colonoscopy.
* Risk factor questionnaire will be completed at time of colonoscopy. Will also try to collect stool from healthy control patients; however, if accrual is low after 3-6 months, remainder of cohort will be filled with specimen data from the Human Microbiome Project Data Portal.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

CRC Cohort:

* 18-49 years old
* Histological or cytological diagnosis of colorectal adenocarcinoma
* Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and/or 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)

Healthy Control Cohort:

* 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)

Exclusion Criteria

* 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

Healthy Control Cohort:

* 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/or genetic predisposition (only patients providing tissue sample).

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes