CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: MRD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage ll or lll<br>Patients with stage ll or lll colorectal cancer | Device: MRD<br>* ctDNA MRD test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence. |  | 7 years | 
| To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers |  | 7 years | 
| To assess time from positive ctDNA to clinical recurrence |  | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal, ctDNA