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Recruiting NCT04739072

NCT04739072 Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study

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Clinical Trial Summary
NCT ID NCT04739072
Status Recruiting
Phase
Sponsor M.D. Anderson Cancer Center
Condition Colorectal Adenocarcinoma
Study Type OBSERVATIONAL
Enrollment 1,000 participants
Start Date 2019-11-22
Primary Completion 2025-12-31

Trial Parameters

Condition Colorectal Adenocarcinoma
Sponsor M.D. Anderson Cancer Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-11-22
Completion 2025-12-31
Interventions
Biospecimen CollectionElectronic Health Record Review

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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 shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years. 2. Histological/cytological confirmation of colorectal adenocarcinoma. 3. 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. 4. Ability to understand and the willingness to sign a written informed consent document. 5. Willing to pursue standard of care surveillance post completion of curative therapies. 6. Willing to provide blood samples for correlative research. Exclusion Criteria: 1. 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. 2. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgmen

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