Collecting stool samples to develop a new cancer detection test
Stool Sample Collection Study for Colorectal Cancer Test Research and Development
This study is collecting stool samples from people with colorectal cancer or significant polyps to see if they can create a new test for detecting cancer in the digestive tract.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innovis LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Trial ID | NCT06294873 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect de-identified stool specimens from participants diagnosed with colorectal cancer or significant polyps found during colonoscopy. Participants will use a specialized stool collection kit at home to gather samples, which will then be sent to the study sponsor for analysis. The goal is to develop a new molecular diagnostic test for detecting neoplasms in the aerodigestive tract. The study emphasizes participant safety and adherence to protocols for sample collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of colorectal cancer or significant colorectal polyps requiring surgical intervention.
Not a fit: Patients with active bleeding hemorrhoids, other active cancers, or certain hereditary cancer syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective diagnostic test for early detection of colorectal and other aerodigestive tract cancers.
How similar studies have performed: Other studies have shown promise in developing molecular diagnostic tests for cancer detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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. -
Where this trial is running
Anaheim, California and 2 other locations
- Associated Gastroenterology Medical Group — Anaheim, California, United States (Recruiting)
- Sarkis Clinical Trials — Ocala, Florida, United States (Recruiting)
- Gastro One — Cordova, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Wallis S Blumm
- Email: wblumm@innovis.net
- Phone: 9172082989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.