Adenocarcinoma of the ColonNCT04624555
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
An observational study of Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Stage I Colorectal Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Gregory Cooper, MD, 800-641-2422, CTUReferral@UHhospitals.org
About this study
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.
Read the 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.
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Stage I Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: at 1 and 4 years
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))
Measured: 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.
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).
Measured: at 1 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start31 Oct 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Cooper, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624555
- Sponsor's protocol ID
- CASE14219
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2020
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT04624555
- Acronym / sponsor ID
- CASE14219
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Stage I Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of mt-sDNA compared to Colonoscopy
Time frame: at 1 and 4 years
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
Time frame: at 1 and 4 years
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.
Time frame: at 1 and 4 years
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Cooper, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Cooper, MD (1-800-641-2422, gregory.cooper@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of mt-sDNA compared to Colonoscopy (time frame: at 1 and 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.