Stool Sample Collection Study

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: 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
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Wallis S Blumm; Phone Number: 9172082989; Email: wblumm@innovis.net
• Study Contact Backup: Name: Gregg S Britt; Phone Number: 3103863000; Email: gbritt@innovis.net

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92810
      • Recruiting
      • Associated Gastroenterology Medical Group
      • Contact: Brian Riff, MD; Phone Number: 227 714-778-1300; Email: briff@agmg.com
      • Principal Investigator: Brian Riff, MD
  • Florida
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Sarkis Clinical Trials
      • Principal Investigator: Vishnu Reddy, MD
      • Contact: Jen Corcoran; Phone Number: 272 352-363-5395; Email: merci@ehsfamily.com
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Recruiting
      • Gastro One
      • Principal Investigator: Ziad Younes, MD
      • Contact: Brian Dragutsky; Phone Number: 901-606-8924; Email: brian.dragutsky@onegi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Men and women 18 years or greater with 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.

Description

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.

   -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Innovis LLC
• Collaborators: Exact Sciences Corporation
• Investigators: Study Director: Gregg S Britt, Innovis LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Innovis RD-2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No