NCT06294873

Stool Sample Collection Study

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Innovis LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2024-03-06
• Last updated: 2024-03-06

Locations

3 sites across 1 country: United States