Colorectal CancerMRDNCT06398743
First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 22 sites in 5 countries.
Trial summary
The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence. 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
- 416 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 20 Jun 2023to Dec 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
- Subject is/has:
- 18 years of age or older.
- 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.
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- Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension form 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 CRC.
- ECOG performance status ≤ 2 (0, 1 or 2).
- Able to understand and provide written informed consent.
- Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.
Who cannot join
- Subject is/has:
- Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
- Known pregnancy 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
22 sites in 5 countries.
22 sites in 5 countries
United Kingdom8 sites
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Edinburgh Cancer Centre
Edinburgh, Scotland, EH4 3NQ
Churchill Hospital
Headington, Oxford, OX3 7LE
Ipswich Hospital
Ipswich, IP4 5PD
Kidderminster Hospital and Treatment Centre
Kidderminster, DY11 6RJ
Alexandra Hospital
Redditch, B98 7UB
Torbay Hospital
Torquay, TQ2 7AA
Worcestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD
Israel6 sites
HaEmek Medical Center
Afula, 1834111
Soroka University Medical Center
Beersheba, Southern District, 8410101
Hillel Yaffe Medical Center
Hadera, North, 3846201
Hadassah University Hospital - Mount Scopus
Jerusalem, 12000
Shaare Zedek Medical Center Jerusalem
Jerusalem, 9312584
Tel Aviv Sourasky Medical Center
Tel Aviv Yaffo, Central District, 64239
Italy3 sites
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20262
Istituto Nazionale Tumori - Fondazione G Pascale
Naples, 20162
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Japan3 sites
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kagawa University Hospital
Kita-gun, 7610793
Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Spain2 sites
Hospital Universitario La Paz
Madrid, 28046
Centro Integral Oncológico Clara Campal (HM CIOCC)
Madrid, 28050
About this study
Official title: CORRECT-MRD I: First Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.
- 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 II or III | Patients with stage II or III 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 post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death.
Measured: 6 years
Secondary outcomes (1)
Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Jun 2023
- Primary completionSep 2027 (estimated)
- Study completionDec 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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
- Investigators
- Somasundaram Subramaniam, MD, Study director, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398743
- Sponsor's protocol ID
- 16-001
- Acronym
- MRD
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRECT-MRD I: First Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT06398743
- Acronym / sponsor ID
- MRD / 16-001
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 May 2024 (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 I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage II or III | – | Device: MRDPatients with stage II or III 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 (11 listed)
- 18 years of age or older.
- 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 CRC.
- ECOG performance status ≤ 2 (0, 1 or 2).
Key exclusion criteria (8 listed)
- Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
- Known pregnancy 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 II or III |
Primary outcome
To validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death.
Time frame: 6 years
1 secondary outcome
Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.
Time frame: 6 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 24 Jul 2025.
- 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.
Somasundaram Subramaniam, MD study director
Exact Sciences
22 sites in 5 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 22 sites in 5 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 11 inclusion and 8 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Israel, Italy, Japan, Spain. 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 post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death. (time frame: 6 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 24 Jul 2025.