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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 : February 2, 2023
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
  2. 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:

    1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
    2. 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 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.

  3. Pathologic stage II or III
  4. ECOG performance status ≤ 2 (0, 1 or 2).
  5. Able to understand and provide written informed consent.
  6. Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.

Exclusion Criteria:

  1. Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
  2. Pregnant or breastfeeding at time of enrollment.
  3. 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.
  4. Prior transplant history:

    1. Prior allogeneic hematopoietic stem cell transplant at any time.
    2. Prior solid organ transplant within the last 2 years prior to enrollment.
  5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

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
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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: February 2, 2023
Last Verified: February 2023
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