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

May 27, 2026 updated by: M.D. Anderson Cancer Center

Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Demonstrate ability to monitor cancer-specific deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma.

II. Improve detection of recurrences post completion of curative therapies through monitoring of plasma cancer-specific DNA, RNA and proteomic alterations.

SECONDARY OBJECTIVES:

I. Qualitative and quantitative changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance.

II. Disease free survival (DFS) of patients with detectable cancer-specific plasma alterations.

III. Overall survival (OS) of patients with detectable cancer-specific plasma alterations.

EXPLORATORY OBJECTIVES:

I. Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences.

II. Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences.

III. Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS.

IV. Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations.

OUTLINE:

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Terminated
        • Banner - MD Anderson Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Terminated
        • Baptist- MD Anderson Cancer Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Terminated
        • The Queen's Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Terminated
        • St. Luke's Cancer Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Terminated
        • Cooper Hospital UNIV MED CTR.
    • Texas
      • Dallas, Texas, United States, 75390
        • Terminated
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Arvind Dasari
      • Houston, Texas, United States, 77030
        • Terminated
        • Houston Methodist Cancer Center
      • San Antonio, Texas, United States, 78229
        • Terminated
        • UT Health San Antonio MD Anderson Cancer Center
      • Temple, Texas, United States, 76508
        • Terminated
        • Baylor Scott & White Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal cancer at MD Anderson Cancer Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Electronic Health Record Review
Review of medical records
Procedure: Biospecimen Collection
Undergo collection of blood and tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance
Time Frame: Baseline up to 5 years
Will assess the association between changes in circulating molecules and response in patients undergoing neoadjuvant therapy by linear or logistic regression models
Baseline up to 5 years
Disease free survival (DFS)
Time Frame: Up to 5 years
Up to 5 years
Overall survival (OS)
Time Frame: Up to 5 years
Up to 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences
Time Frame: Up to 5 years
Up to 5 years
Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences
Time Frame: Up to 5 years
Up to 5 years
Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS
Time Frame: Up to 5 years
Up to 5 years
Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Arvind Dasari, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA18-1171 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-10034 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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