NCT06294873

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 28, 2024

Last Update Submit

February 28, 2024

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

DNA test to screen to detect colon cancer and precancerous lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Participant is a person ≥18 years of age.
  • 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.
  • 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.

You may not qualify if:

  • Participant has actively bleeding hemorrhoids.
  • Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  • Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
  • Participant has a history of any inflammatory bowel disease.
  • Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  • Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Associated Gastroenterology Medical Group

Anaheim, California, 92810, United States

RECRUITING

Sarkis Clinical Trials

Ocala, Florida, 34474, United States

RECRUITING

Gastro One

Cordova, Tennessee, 38018, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gregg S Britt

    Innovis LLC

    STUDY DIRECTOR

Central Study Contacts

Wallis S Blumm

CONTACT

9172082989wblumm@innovis.net

Gregg S Britt

CONTACT

3103863000gbritt@innovis.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

July 20, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)