Stool Sample Collection Study

Colorectal Cancer Clinical Trial

Official title:

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294873
• Other study ID #: Innovis RD-2301
• Status: Recruiting
• Start date: July 20, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Innovis LLC
• Contact: Wallis S Blumm
• Phone: 9172082989
• Email: wblumm[@]innovis.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• A screening device for the detection of colorectal and other aerodigestive tract cancers
DNA test to screen to detect colon cancer and precancerous lesions

Locations

Country	Name	City	State
United States	Associated Gastroenterology Medical Group	Anaheim	California
United States	Gastro One	Cordova	Tennessee
United States	Sarkis Clinical Trials	Ocala	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Innovis LLC	Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of colon cancer or precancer	To provide stool specimens to Exact Sciences to allow for additional research and development of a screening device for the detection of colorectal and other aerodigestive tract cancers.	10 months