RECRUITING

Stool Sample Collection Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

Quick Facts

Study Start:2023-07-20
Study Completion:2024-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06294873

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant is a person ≥18 years of age.
  2. 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. 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. 1. Participant has actively bleeding hemorrhoids.
  2. 2. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  3. 3. Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
  4. 4. Participant has a history of any inflammatory bowel disease.
  5. 5. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  6. 6. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.
  7. 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.

Contacts and Locations

Study Contact

Wallis S Blumm
CONTACT
9172082989
wblumm@innovis.net
Gregg S Britt
CONTACT
3103863000
gbritt@innovis.net

Principal Investigator

Gregg S Britt
STUDY_DIRECTOR
Innovis LLC

Study Locations (Sites)

Associated Gastroenterology Medical Group
Anaheim, California, 92810
United States
Sarkis Clinical Trials
Ocala, Florida, 34474
United States
Gastro One
Cordova, Tennessee, 38018
United States

Collaborators and Investigators

Sponsor: Innovis LLC

  • Gregg S Britt, STUDY_DIRECTOR, Innovis LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20
Study Completion Date2024-04-30

Study Record Updates

Study Start Date2023-07-20
Study Completion Date2024-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer