Stool Sample Collection Study

Description

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.

Conditions

Colorectal Cancer

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Study Overview

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Study Details

Study overview

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.

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

Stool Sample Collection Study

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Anaheim

Associated Gastroenterology Medical Group, Anaheim, California, United States, 92810

Ocala

Sarkis Clinical Trials, Ocala, Florida, United States, 34474

Cordova

Gastro One, Cordova, Tennessee, United States, 38018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participant is a person ≥18 years of age.
  • 2. 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.
  • 3. 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.
  • 1. Participant has actively bleeding hemorrhoids.
  • 2. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  • 3. Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
  • 4. Participant has a history of any inflammatory bowel disease.
  • 5. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  • 6. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.
  • 7. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innovis LLC,

Gregg S Britt, STUDY_DIRECTOR, Innovis LLC

Study Record Dates

2024-04-30