Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
Recruiting · NCT04739072 · Observational (researchers observe without assigning treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionElectronic Health Record Review
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
10 locations listed across 6 US states.
- Banner - MD Anderson Cancer Center - Gilbert, Arizona, United States
- Baptist- MD Anderson Cancer Center - Jacksonville, Florida, United States
- The Queen's Medical Center - Honolulu, Hawaii, United States
- St. Luke's Cancer Institute - Boise, Idaho, United States
- Cooper Hospital UNIV MED CTR. - Camden, New Jersey, United States
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas, Texas, United States
- Houston Methodist Cancer Center - Houston, Texas, United States
- M D Anderson Cancer Center - Houston, Texas, United States
- UT Health San Antonio MD Anderson Cancer Center - San Antonio, Texas, United States
- Baylor Scott & White Research Institute - Temple, Texas, United States