Trial record 1 of 1 for:
correct-MRD II
CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer (MRD)
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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 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2022
Last Update Posted : February 2, 2023
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Sponsor:
Exact Sciences Corporation
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
Exact Sciences Corporation
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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 |
| 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 |
|---|---|
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Stage ll or lll
Patients with stage ll or lll colorectal cancer
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Device: MRD
ctDNA MRD test |
Primary Outcome Measures :
- To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). [ Time Frame: 7 years ]
Secondary Outcome Measures :
- 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 ]
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:
- Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
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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 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
- 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 43mL of blood for each research blood draw.
Exclusion Criteria:
- 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.
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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.
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
| Contact: NSABP Department of Site and Study Management Department of Site and Study Management | 1-800-270-3165 | industry.trials@nsabp.org |
Locations
Show 29 study locations
Sponsors and Collaborators
Exact Sciences Corporation
NSABP Foundation Inc
| 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. |
| 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:
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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 |