Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
NCT ID: NCT04739072
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2019-11-22
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood and tissue samples
Electronic Health Record Review
Review of medical records
Interventions
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Biospecimen Collection
Undergo collection of blood and tissue samples
Electronic Health Record Review
Review of medical records
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Arvind Dasari
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Arvind Dasari
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2020-10034
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA18-1171
Identifier Type: OTHER
Identifier Source: secondary_id
PA18-1171
Identifier Type: -
Identifier Source: org_study_id