Clinical trial NCT04624555: The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Official title: The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Stage I Colorectal Cancer
Stage II Colorectal Cancer
Stage III Colorectal Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are diagnosed with stage I-III colorectal cancer. All participants who are within 1 year of colon cancer resection will be asked to participate in the study.

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.

Detailed description: Participants who were diagnosed with Stage I-III colorectal cancer will undergo testing with mt-sDNA followed by a questionnaire about satisfaction with mt-sDNA (multitarget stool DNA panel), prior to their scheduled colonoscopies at years 1 and 4 after diagnosis.

Participants will be asked to provide a stool sample for mt-sDNA (Cologuard) testing that will be collected within 90 days before their scheduled colonoscopy. The kit will be given to the participant by study personnel and mailed back directly to Exact Science.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of mt-sDNA compared to Colonoscopy
timeFrame: at 1 and 4 years
measure: Specificity of mt-sDNA compared to Colonoscopy
timeFrame: at 1 and 4 years
measure: Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey.
timeFrame: at 1 and 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Gregory Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: