Colorectal AdenocarcinomaNCT04739072
Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
An observational study of Colorectal Adenocarcinoma and Stage I Colorectal Cancer AJCC v8, run by M.D. Anderson Cancer Center at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Nov 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer at MD Anderson Cancer Center.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 1 recruiting
- Terminated
St. Luke's Cancer Institute
Boise, Idaho, 83712
- Terminated
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103
- Terminated
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Terminated
Banner - MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Terminated
The Queen's Medical Center
Honolulu, Hawaii, 96813
- Terminated
Houston Methodist Cancer Center
Houston, Texas, 77030
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Arvind Dasari, 713-792-2828, adasari@mdanderson.org
Arvind Dasari
- Terminated
Baptist- MD Anderson Cancer Center
Jacksonville, Florida, 32207
- Terminated
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229
- Terminated
Baylor Scott & White Research Institute
Temple, Texas, 76508
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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
- Colorectal Adenocarcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and tissue samples
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (3)
Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance
Will assess the association between changes in circulating molecules and response in patients undergoing neoadjuvant therapy by linear or logistic regression models
Measured: Baseline up to 5 years
Disease free survival (DFS)
Measured: Up to 5 years
Overall survival (OS)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start22 Nov 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvind Dasari, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739072
- Sponsor's protocol ID
- PA18-1171
- Other IDs
- NCI-2020-10034, PA18-1171
- Status last verified
- May 2026
- First submitted
- 2 Feb 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)
- ClinicalTrials.gov ID
- NCT04739072
- Acronym / sponsor ID
- PA18-1171
- Conditions
- Colorectal Adenocarcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer at MD Anderson Cancer Center.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and tissue samples | Procedure or surgery | Ancillary-correlative (biospecimen collection) |
| Electronic Health Record ReviewReview of medical records | Other | Ancillary-correlative (biospecimen collection) |
Primary outcome
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.
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.
3 secondary outcomes
Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance
Time frame: Baseline up to 5 years
Disease free survival (DFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arvind Dasari principal investigator
M.D. Anderson Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma and Stage I Colorectal Cancer AJCC v8, run by M.D. Anderson Cancer Center at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arvind Dasari ((713) 792-2828, adasari@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.