About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity of mt-sDNA compared to Colonoscopy
Compare the results between mt-sDNA (categorized as a single positive or negative result) with the findings at colonoscopy, the "gold standard". Colonoscopy will be considered positive if an adenoma or carcinoma is found and otherwise negative. Sensitivity is defined as True Positive (TP)/(TP+ False Negative (FN))
Specificity of mt-sDNA compared to Colonoscopy
Compare the results between mt-sDNA (categorized as a single positive or negative result) with the findings at colonoscopy, the "gold standard". Colonoscopy will be considered positive if an adenoma or carcinoma is found and otherwise negative. Specificity is defined as True Negative (TN)/(TN+ False Positive (FP))
Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey.
Participant acceptance as measured by the Stool Test Satisfaction Survey, which includes 14 questions scored on a Likert scale. Possible scores ranging from 14 - 70, with higher scores indicating better outcomes. Responses will be grouped based on the distribution, but most likely as 1-2 (neutral, unfavorable or least favorable ) versus 3-5 (most favorable or very favorable).
Sponsors and contacts
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