Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT04624555

Conditions

Adenocarcinoma of the Colon

Adenocarcinoma of the Rectum

Stage I Colorectal Cancer

Stage II Colorectal Cancer

Stage III Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.

Conditions

Adenocarcinoma of the Colon

Adenocarcinoma of the Rectum

Stage I Colorectal Cancer

Stage II Colorectal Cancer

Stage III Colorectal Cancer

Study ID

NCT04624555

Start date

Oct 31, 2022

Status verified date

Apr, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum
  • Receipt of preoperative colonoscopy
  • Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated

Exclusion Criteria:

  • Stage IV colorectal cancer
  • Surgical treatment with subtotal colectomy or total proctocolectomy
  • Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis
  • Presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen.
  • Inability to provide informed consent
  • Inability to understand spoken and written English
  • Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Sensitivity of mt-sDNA compared to Colonoscopy [ Time Frame: at 1 and 4 years ]
  • Specificity of mt-sDNA compared to Colonoscopy [ Time Frame: at 1 and 4 years ]
  • Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey. [ Time Frame: at 1 and 4 years ]

Central Contacts and Locations

Central contacts

Gregory Cooper, MD

1-800-641-2422gregory.cooper@uhhospitals.org

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gregory Cooper, MD

800-641-2422CTUReferral@UHhospitals.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-04-09.