The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Stage I Colorectal Cancer, Stage II Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland
Identifiers
NCT: NCT04624555 · CASE14219