Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
2 other identifiers
observational
1,000
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2019
CompletedFirst Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 13, 2025
November 1, 2025
6.1 years
February 2, 2021
November 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma
To detect circulating tumor DNA (ctDNA) in plasma samples from patients with colorectal cancer (CRC) who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.
Up to 5 years
Detection of recurrences post completion of curative therapies
To detect ctDNA in plasma samples from patients with CRC who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.
Up to 5 years
Secondary Outcomes (3)
Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance
Baseline up to 5 years
Disease free survival (DFS)
Up to 5 years
Overall survival (OS)
Up to 5 years
Other Outcomes (4)
Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences
Up to 5 years
Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences
Up to 5 years
Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS
Up to 5 years
- +1 more other outcomes
Study Arms (1)
Ancillary-correlative (biospecimen collection)
Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients medical records may also be reviewed.
Interventions
Undergo collection of blood and tissue samples
Review of medical records
Eligibility Criteria
Patients with colorectal cancer at MD Anderson Cancer Center.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Banner - MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Baptist- MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
St. Luke's Cancer Institute
Boise, Idaho, 83712, United States
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229, United States
Baylor Scott & White Research Institute
Temple, Texas, 76508, United States
Related Links
Biospecimen
Blood and tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arvind Dasari
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 4, 2021
Study Start
November 22, 2019
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
November 13, 2025
Record last verified: 2025-11