Use of ctDNA for Monitoring of Stage III Colorectal Cancer
November 4, 2025 updated by: Robert Schoen, University of Pittsburgh
This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover.
Characteristic of the malignant process, ctDNA can be assessed in plasma and offers the potential of a sensitive and specific biomarker for prognostic information on disease-free or overall survival, and predictive information on chemotherapy resistance and probability of lack of response to treatment.
This study will evaluate ctDNA as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).
We will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (>10 ml), serial plasma specimens every 3 months for up to 3 years and every 6 months in years 4-5 for ctDNA and concurrent carcinoembryonic antigen (CEA) measurement.
Clinical outcome and survival will be tracked.
The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival and as a monitor of disease recurrence in comparison with CEA.
Study Type
Observational
Enrollment (Actual)
137
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who present in a UPMC Cancer Center and meet the criteria for this study will be approached by their treating physician about participation.
Description
Inclusion Criteria:
- Men and women with CRC Stage III A, B, or C
- Age ≥18 years
- Willingness to provide blood samples for research purposes
- Ability to understand written informed consent document, and written informed consent provided
Exclusion Criteria:
- Blood sampling would compromise patients overall health such as presence of severe anemia
- Unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ctDNA assessment and relation to clinical outcome
Time Frame: up to 5 years
|
The relationship between ctDNA and survival (both progression-free and overall) will be evaluated.
Both the total load of ctDNA and the specific mutation(s) identified will be evaluated.
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ctDNA versus CEA
Time Frame: up to 5 years
|
ctDNA predictors of outcome will be compared to CEA
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Schoen, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
July 21, 2016
First Posted (Estimated)
July 22, 2016
Study Record Updates
Last Update Posted (Estimated)
November 6, 2025
Last Update Submitted That Met QC Criteria
November 4, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19070371
- U01CA152753 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be made available according to NIH data sharing policies.
IPD Sharing Time Frame
De-identified individual participant data will be made available according to NIH data sharing policies.
IPD Sharing Access Criteria
De-identified individual participant data will be made available according to NIH data sharing policies.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.