Recruiting

Observational Study

Sponsor:

Innovis LLC

Code:

NCT06294873

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A screening device for the detection of colorectal and other aerodigestive tract cancers

Study Details

Brief 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.

Conditions

Colorectal Cancer

Study ID

NCT06294873

Start date

Jul 20, 2023

Status verified date

Feb, 2024

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

A screening device for the detection of colorectal and other aerodigestive tract cancers

DNA test to screen to detect colon cancer and precancerous lesions

Primary outcome measure

  • Detection of colon cancer or precancer [ Time Frame: 10 months ]

Central Contacts and Locations

Central contacts

Locations

Associated Gastroenterology Medical Group

Recruiting

Anaheim, California, United States, 92810

Contacts

Principal Investigator:

Brian Riff, MD

Sarkis Clinical Trials

Recruiting

Ocala, Florida, United States, 34474

Contacts

Principal Investigator:

Vishnu Reddy, MD

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Principal Investigator:

Ziad Younes, MD

More Information

Sponsor

Innovis LLC

Last update posted

Mar 6, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovis LLC on 2024-03-06.