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Investigation of the Possible Effects of Medication on Young Onset Colorectal Cancer
Trial Status: active
This study investigates the potential effects of medication on patients with young onset colorectal cancer (YOCRC). Researchers have noticed that people have been developing YOCRC more often in the past few decades (since the mid-1990s). Researchers do not know the reason for this increased occurrence, but some researchers suspect one or more medications routinely prescribed by doctors could be triggering the onset of YOCRC. This study may help researchers learn about the role standard medications may play in the increased occurrence of YOCRC. Researchers will also use the information to learn more about how YOCRC may be similar or different from colorectal cancer diagnosed later in life.
Inclusion Criteria
CRC COHORT: 18-49 years old
CRC COHORT: Histological or cytological diagnosis of colorectal adenocarcinoma
CRC COHORT: Planned CRC resection or 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).of primary colon cancer (only patients providing tissue sample)
CRC COHORT: Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, principal investigator [PI])
HEALTHY CONTROL COHORT: 18-49 years old at time of diagnosis
HEALTHY CONTROL COHORT: Scheduled for standard-of-care colonoscopy at Memorial Sloan Kettering (MSK)
HEALTHY CONTROL COHORT: Underwent surgical resection of a traumatic injury to the colon at SZMC
Exclusion Criteria
CRC COHORT: Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)
CRC COHORT: Known inherited cancer susceptibility gene
CRC COHORT: 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)
HEALTHY CONTROL COHORT: 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
HEALTHY CONTROL COHORT: Colonoscopy for indications of inflammatory bowel disease (IBD) and/or genetic predisposition (only patients providing tissue sample)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05568420.
I. To establish a prospective database of patients with young onset colorectal cancer and control patients, from whom biological specimens are collected to test the hypothesis that a drug or drug class prescribed for other indications is related to the increased incidence of young onset colorectal cancer.
II. Analysis of biospecimens including normal colonic mucosae of affected and control patients, and stool for gut microbiome and microbiome metabolites:
IIa. Characterize the frequency of genetic variants related to pathways targeted by prescription medications used more frequently in YOCRC patients compared to unaffected controls;
IIb. Characterize the gut microbiome and microbiome metabolites of YOCRC patients using tissue analysis of colon mucosa from resected colon cancers and from control patients.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.
GROUP 1: Patients with YOCRC undergo standard of care surgery or colonoscopy with biopsy, blood and stool sample collection, complete questionnaires and have their electronic medical records reviewed on study.
GROUP 2: Healthy participants undergo standard of care colonoscopy with biopsy, blood sample collection, complete questionnaires and have their electronic medical records reviewed on study.
Patients are followed every 3 months for up to 1 year.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
