Stool Sample Collection Study

Status unconfirmed

Conditions studied: Colorectal Cancer

In brief

The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract.

Key facts

Study ID

NCT06294873

Run by

Innovis LLC

People needed

40

Starts

2023-07-20

Expected to finish

2024-04-30

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is a person ≥18 years of age.
• Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
• Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if…

• Participant has actively bleeding hemorrhoids.
• Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
• Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
• Participant has a history of any inflammatory bowel disease.
• Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
• Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.
• Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Where it is running

• Associated Gastroenterology Medical Group — Anaheim, California, United States (enrolling)
• Sarkis Clinical Trials — Ocala, Florida, United States (enrolling)
• Gastro One — Cordova, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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