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

RECRUITINGSponsored by M.D. Anderson Cancer Center
Actively Recruiting
SponsorM.D. Anderson Cancer Center
Started2019-11-22
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations10 sites

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

Age: 18 Years+Healthy volunteers accepted
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 judgment of the investigator, would make the patient inappropriate for entry into this study.

Conditions15

CancerColorectal AdenocarcinomaStage I Colorectal Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8

Locations10 sites

Banner - MD Anderson Cancer Center
Gilbert, Arizona, 85234
Baptist- MD Anderson Cancer Center
Jacksonville, Florida, 32207
The Queen's Medical Center
Honolulu, Hawaii, 96813
St. Luke's Cancer Institute
Boise, Idaho, 83712
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103

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