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Trial record 1 of 1 for:    correct-MRD II
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CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer (MRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05210283
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : October 12, 2022
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
Exact Sciences Corporation

Brief Summary:
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for a minimum of 3 years and up to 5 years for recurrence.

Condition or disease Intervention/treatment
Colorectal Cancer Device: MRD

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : February 15, 2028
Estimated Study Completion Date : February 15, 2028

Group/Cohort Intervention/treatment
Stage ll or lll
Patients with stage ll or lll colorectal cancer
Device: MRD
ctDNA MRD test




Primary Outcome Measures :
  1. To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence. [ Time Frame: 7 years ]
  2. To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers [ Time Frame: 7 years ]
  3. To assess time from positive ctDNA to clinical recurrence [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer
Criteria

Inclusion Criteria:

  1. Histologic diagnosis of carcinoma of the colon or rectum
  2. Undergone complete surgical resection of the primary tumor within 3 months prior to enrollment.
  3. Pathologic stage II or III

    1. Stage II patients must be microsatellite stable (MSS) and/or mismatch repair (MMR)-proficient.
    2. Stage III patients are eligible regardless of microsatellite instability (MSI) or MMR status.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  5. No clinical contraindication to adjuvant chemotherapy.

Exclusion Criteria:

  1. Received prior systemic anti-cancer therapy.
  2. Pregnant or breastfeeding at time of enrollment.
  3. Prior history and treatment for any invasive cancer within the past 5 years, with the exception of non-melanoma skin cancer
  4. Has a known history of an inherited genetic condition associated with an increased risk of colorectal cancer, with the exception of Lynch Syndrome in Stage III patients.
  5. MMR deficient tumor or germline MMR deficiency (Lynch Syndrome) with Stage II colorectal cancer.
  6. Prior stem cell transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05210283


Contacts
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Contact: NSABP Department of Site and Study Management Department of Site and Study Management 1-800-270-3165 industry.trials@nsabp.org

Locations
Show Show 27 study locations
Sponsors and Collaborators
Exact Sciences Corporation
NSABP Foundation Inc
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT05210283    
Other Study ID Numbers: 16-002
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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 (IRB)/Institutional Ethics Committee (IEC) approvals or waivers as applicable to conduct research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Exact Sciences Corporation:
Colorectal
ctDNA
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm, Residual
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes