Use of ctDNA for Monitoring of Stage III Colorectal Cancer
2 other identifiers
observational
137
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
November 6, 2025
November 1, 2025
10 years
July 20, 2016
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ctDNA assessment and relation to clinical outcome
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 Outcomes (1)
ctDNA versus CEA
up to 5 years
Eligibility Criteria
Patients who present in a UPMC Cancer Center and meet the criteria for this study will be approached by their treating physician about participation.
You may qualify if:
- 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
You may not qualify if:
- Blood sampling would compromise patients overall health such as presence of severe anemia
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Related Publications (1)
Borhani AA, Zhang P, Diergaarde B, Darwiche S, Chuperlovska K, Wang SC, Schoen RE, Su GL. Role of tumor-specific and whole-body imaging biomarkers for prediction of recurrence in patients with stage III colorectal cancer. Abdom Radiol (NY). 2025 May;50(5):1907-1915. doi: 10.1007/s00261-024-04656-3. Epub 2024 Nov 2.
PMID: 39487920DERIVED
Biospecimen
blood samples; formalin-fixed, paraffin-embedded tumor blocks
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Schoen, MD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine & Epidemiology
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 22, 2016
Study Start
September 1, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified individual participant data will be made available according to NIH data sharing policies.
- Access Criteria
- De-identified individual participant data will be made available according to NIH data sharing policies.
De-identified individual participant data will be made available according to NIH data sharing policies.