The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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))

Time frame
at 1 and 4 years
2

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))

Time frame
at 1 and 4 years
3

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).

Time frame
at 1 and 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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