NCT06398743

Brief 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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
5 countries

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2023Dec 2027

Study Start

First participant enrolled

June 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4.2 years

First QC Date

April 24, 2024

Last Update Submit

July 21, 2025

Conditions

Colorectal Cancer

Keywords

ColorectalctDNA

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 years

Secondary Outcomes (1)

  • Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.

    6 years

Study Arms (1)

Stage II or III

Patients with stage II or III colorectal cancer

Device: MRD

Interventions

MRDDEVICE

ctDNA MRD test

Stage II or III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer

You may qualify if:

  • Subject is/has:
  • 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.
  • i. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Tel Aviv Sourasky Medical Center

Tel Aviv Yaffo, Central District, 64239, Israel

Location

Hillel Yaffe Medical Center

Hadera, North, 3846201, Israel

Location

Soroka University Medical Center

Beersheba, Southern District, 8410101, Israel

Location

HaEmek Medical Center

Afula, 1834111, Israel

Location

Hadassah University Hospital - Mount Scopus

Jerusalem, 12000, Israel

Location

Shaare Zedek Medical Center Jerusalem

Jerusalem, 9312584, Israel

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20262, Italy

Location

Istituto Nazionale Tumori - Fondazione G Pascale

Napoli, 20162, Italy

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Kagawa University Hospital

Kita-gun, 7610793, Japan

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Centro Integral Oncológico Clara Campal (HM CIOCC)

Madrid, 28050, Spain

Location

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

Edinburgh Cancer Centre

Edinburgh, Scotland, EH4 3NQ, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, Worcestershire, WR5 1DD, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

Location

Kidderminster Hospital and Treatment Centre

Kidderminster, DY11 6RJ, United Kingdom

Location

Alexandra Hospital

Redditch, B98 7UB, United Kingdom

Location

Torbay Hospital

Torquay, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Somasundaram Subramaniam, MD

    Exact Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 3, 2024

Study Start

June 20, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available from 2 years and ending 4 years after publication
Access Criteria
Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary institutional review board/independent ethics committee approvals or waivers as applicable to conduct research.

Locations

GB(8)ES(2)IT(3)IL(6)JP(3)