CORRECT-MRD II: Second COloRectal cancer clinical validation study to predict Recurrence using a Circulating Tumor DNA assay to detect Minimal Residual Disease

  • Clinical Trial Information

    Trial Contact: Djuro, Victor; Donaldson, Karin M

    Trial Phone: 321.841.7477 ; 321.841.9821

  • IRB No: Pro00057311

    Protocol Abbrev: NSABP C-14

    Principal Investigator: Omar R. Kayaleh, MD

    Phase: Device: Category N/A

    Age Group: Adult

    Secondary Protocol No: 16-002/ CORRECT-MRD II

    Treatment: A post-op blood draw ID: NCT05210283

  • Objective

    PRIMARY: To validate the association of post-surgery baseline and pre-recurrence follow-up ctDNA positivity with recurrence-free interval (RFI).

    SECONDARY:  To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.
     To assess the contribution of post-surgery baseline, post-adjuvant therapy, and pre-recurrence follow-up ctDNA results (as a time-dependent covariate) on RFI. These ctDNA results will be assessed for their contribution independent of clinicopathological risk features, serial serum CEA, and recurrence risk as estimated using RS.  To assess time from positive ctDNA to clinical recurrence in subjects who had a positive ctDNA result.  To compare the RS estimate of 3-year recurrence risk with the observed 3-year recurrence rate.

    EXPLORATORY:  To describe overall survival for each of the following groups:
     +/+: ctDNA+ at baseline and remain positive throughout follow-up.
     +/-: ctDNA+ at baseline and convert to negative during follow-up.  -/+: ctDNA- at baseline and convert to positive during follow-up.
     -/-: ctDNA- at baseline and throughout follow-up.
     To describe time to progression (or second recurrence, if first recurrence was a resectable oligometastasis), in patients with targetable mutations found vs not found using Oncotype MAP-t results and describe treatments received.
     Examine differences between Oncotype MAP-t results in primary vs recurrent tissue.
     To assess the association with RFI of baseline ctDNA results measured at 14-28 days post-surgery as compared to 29 days or more.

  • Key Eligibility

    Inclusion criteria:
    Subject is/has: 1. 18 years of age or older.
    2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
    3. Undergone complete surgical resection of the primary tumor within 3 months prior to enrollment.
    4. Pathologic stage II or III colorectal cancer. a. Stage II patients must be microsatellite stable (MSS) and/or MMR-p. b. Stage III patients are eligible regardless of microsatellite instability (MSI) or MMR status.
    5. ECOG performance status ≤ 2.
    6. Clinically eligible for adjuvant chemotherapy according to treating physician’s decision and institutional guidelines.
    7. Able to read, understand and provide written informed consent.
    8. Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.