The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Recruiting · NCT04624555 · Observational (researchers observe without assigning treatment) · Lead sponsor: Case Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland, Ohio, United States