Colorectal CancerMRDNCT05210283
CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 32 sites in 2 countries.
Trial summary
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Maximum duration of participant participation is up to seven years from enrollment to study completion with up to five years of active follow up and up to two years of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- MRD
- Type of treatment
- Medical device
- How many people
- 1,017 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 15 Dec 2021to 15 May 2027
- 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 over the age of 18 who have undergone surgery for stage II or III colorectal cancer
Who may be able to join
- Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
- Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:
- in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
- histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.
- Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
- Pathologic stage II or III
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- ECOG performance status ≤ 2 (0, 1 or 2).
- Able to understand and provide informed consent.
- Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.
Who cannot join
- Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
- Pregnant or breastfeeding at time of enrollment.
- Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
- Prior transplant history:
- Prior allogeneic hematopoietic stem cell transplant at any time.
- Prior solid organ transplant within the last 2 years prior to enrollment.
- Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States28 sites
MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital
Baltimore, Maryland, 21237
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
Columbus NCORP
Columbus, Ohio, 43215
Edward Cancer Center
Elmhurst, Illinois, 60126
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58104
University of Florida Division of Hematology & Oncology
Gainesville, Florida, 32610
Primsa Health Cancer Institute
Greenville, South Carolina, 29605
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Ballad Health Cancer Center
Kingsport, Tennessee, 37660
Mount Sinai Medical - Comprehensive Cancer Center
Miami Beach, Florida, 33140
Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology
Mission Hills, California, 91345
Mid Florida Cancer Centers
Orange City, Florida, 32763
Illinois Cancer Care
Peoria, Illinois, 61615
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Interstate Medical Office Central
Portland, Oregon, 97227
Metro Minnesota Community Oncology Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Torrance Memorial Hunt Cancer Institute
Torrance, California, 90505
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21093
Reading Hospital Hematology Oncology
West Reading, Pennsylvania, 19611
Marshfield Medical Center Weston
Weston, Wisconsin, 54476
University of Kansas Cancer Center
Westwood, Kansas, 66205
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
WellSpan York Cancer Center
York, Pennsylvania, 17403
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Jewish General Hospital
Montreal, Quebec, H3T1E2
McGill University Health - Glen Site
Montreal, Quebec, H4A3J1
Princess Margaret Cancer Center
Toronto, Ontario, M5G2C1
About this study
Official title: CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Maximum duration of participant participation is up to seven years from enrollment to study completion with up to five years of active follow up and up to two years of clinical (passive) follow up.
- Conditions
- Colorectal Cancer
- Being tested
- MRD
- Keywords
- Colorectal, ctDNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRDDevice
ctDNA MRD test
| Study group | Role | What they receive |
|---|---|---|
| Stage ll or lll | Patients with stage ll or lll colorectal cancer Receives: Device: MRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
Measured: 7 years
Secondary outcomes (3)
To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.
Measured: 7 years
To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers
Measured: 7 years
To assess time from positive ctDNA to clinical recurrence
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Dec 2021
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NSABP Foundation Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210283
- Sponsor's protocol ID
- 16-002
- Acronym
- MRD
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figured, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable). May not be reproduced nor disseminated outside of Exact Sciences without permission and the clinical study report (when applicable) will also be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT05210283
- Acronym / sponsor ID
- MRD / 16-002
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- NSABP Foundation Inc
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 27 Jan 2022 (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.
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Maximum duration of participant participation is up to seven years from enrollment to study completion with up to five years of active follow up and up to two years of clinical (passive) follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage ll or lll | – | Device: MRDPatients with stage ll or lll colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer
Key inclusion criteria (9 listed)
- Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
- Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:
- Pathologic stage II or III
- ECOG performance status ≤ 2 (0, 1 or 2).
- Able to understand and provide informed consent.
Key exclusion criteria (7 listed)
- Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
- Pregnant or breastfeeding at time of enrollment.
- Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
- Prior transplant history:
- Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
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 |
|---|---|---|
| MRDctDNA MRD test | Device | Stage ll or lll |
Primary outcome
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
Time frame: 7 years
3 secondary outcomes
To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.
Time frame: 7 years
To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers
Time frame: 7 years
To assess time from positive ctDNA to clinical recurrence
Time frame: 7 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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figured, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable). May not be reproduced nor disseminated outside of Exact Sciences without permission and the clinical study report (when applicable) will also be shared
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 32 sites in 2 countries.
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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). (time frame: 7 years). 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 12 Jan 2026.