Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06294873 | RECRUITING | Colorectal Cancer

Stool Sample Collection Study
Sponsor:

Innovis LLC

Brief Summary:

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.

Condition or disease

Colorectal Cancer

Intervention/treatment

A screening device for the detection of colorectal and other aerodigestive tract cancers

Detailed Description:

Participants providing written informed consent to participate in the study will be provided with a stool collection kit with multiple components. Participants will perform whole stool collection at home using a standardized whole stool collection device designed to fit over the toilet seat. The kit will also include a small, white-capped collection tube which participants will be instructed to use to collect a stool sample from the whole stool to allow for a fecal immunochemical test (FIT). In addition, the kit will contain an investigational device that includes a collection scoop and buffering solution. The investigational device will be used by participants to collect a stool sample from the whole stool. After the two (2) samples are collected from the whole stool, a buffering solution will then be poured over the remaining whole stool. The residual buffered whole stool, the sample in the small, white-capped collection tube (FIT) and the partial stool sample in the investigational collection device will be returned to the Sponsor in a self-shipping box, per the instructions provided to the participants. All stool samples will be provided ≥7 days post-colonoscopy and prior to initiating bowel preparation for surgery, and/or neoadjuvant chemotherapy, radiation therapy, and/or follow-up therapeutic colonoscopy.

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Stool Sample Collection Study for Colorectal Cancer Test Research and Development
Actual Study Start Date : 2023-07-20
Estimated Primary Completion Date : 2024-04-30
Estimated Study Completion Date : 2024-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
Exclusion Criteria
  • 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.
  • -
Stool Sample Collection Study

Location Details

NCT06294873

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Associated Gastroenterology Medical Group

Anaheim, California, United States, 92810

RECRUITING

United States, Florida

Sarkis Clinical Trials

Ocala, Florida, United States, 34474

RECRUITING

United States, Tennessee

Gastro One

Cordova, Tennessee, United States, 38018