Status:
RECRUITING
Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Colorectal Adenocarcinoma
Stage I Colorectal Cancer AJCC v8
Eligibility:
All Genders
18+ years
Brief Summary
This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors...
Detailed Description
PRIMARY OBJECTIVES: I. Demonstrate ability to monitor cancer-specific deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma. II. Improve detection of recurrences...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histological/cytological confirmation of colorectal adenocarcinoma.
- Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to pursue standard of care surveillance post completion of curative therapies.
- Willing to provide blood samples for correlative research.
Exclusion
- Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and / or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04739072
Start Date
November 22 2019
End Date
December 31 2025
Last Update
November 13 2025
Active Locations (10)
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1
Banner - MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Baptist- MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
3
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
4
St. Luke's Cancer Institute
Boise, Idaho, United States, 83712