Assessing minimal residual disease in colorectal cancer patients
Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)
This study is testing if checking for certain cancer-related markers in the blood can help predict if colorectal cancer will come back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 10 sites (Gilbert, Arizona and 9 other locations) |
| Trial ID | NCT04739072 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential of circulating tumor DNA (ctDNA) and other tumor-related molecules in the blood to predict the recurrence or spread of colorectal cancer. It aims to monitor cancer-specific DNA, RNA, and proteomic changes from plasma samples collected at various stages of treatment and follow-up. The study will analyze these alterations to improve detection of cancer recurrences post-curative therapies and assess their correlation with patient outcomes such as disease-free survival and overall survival.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed colorectal adenocarcinoma at any stage, who are eligible for curative treatment.
Not a fit: Patients with active malignancies other than colorectal adenocarcinoma or severe concurrent diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict colorectal cancer recurrence, leading to timely interventions and improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer monitoring, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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 judgment of the investigator, would make the patient inappropriate for entry into this study.
Where this trial is running
Gilbert, Arizona and 9 other locations
- Banner - MD Anderson Cancer Center — Gilbert, Arizona, United States (Terminated)
- Baptist- MD Anderson Cancer Center — Jacksonville, Florida, United States (Terminated)
- The Queen's Medical Center — Honolulu, Hawaii, United States (Terminated)
- St. Luke's Cancer Institute — Boise, Idaho, United States (Terminated)
- Cooper Hospital UNIV MED CTR. — Camden, New Jersey, United States (Terminated)
- UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States (Terminated)
- Houston Methodist Cancer Center — Houston, Texas, United States (Terminated)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- UT Health San Antonio MD Anderson Cancer Center — San Antonio, Texas, United States (Terminated)
- Baylor Scott & White Research Institute — Temple, Texas, United States (Terminated)
Study contacts
- Principal investigator: Arvind Dasari — M.D. Anderson Cancer Center
- Study coordinator: Arvind Dasari
- Email: adasari@mdanderson.org
- Phone: (713) 792-2828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.