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MRD: CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Sponsor
Exact Sciences Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05210283
Collaborator
NSABP Foundation Inc (Other)
750
Enrollment
21
Locations
74
Anticipated Duration (Months)
35.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: MRD

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 15, 2021
Anticipated Primary Completion Date :
Feb 15, 2028
Anticipated Study Completion Date :
Feb 15, 2028

Arms and Interventions

Arm Intervention/Treatment
Stage ll or lll

Patients with stage ll or lll colorectal cancer

Device: MRD
ctDNA MRD test

Outcome Measures

Primary Outcome Measures

  1. To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). [7 years]

Secondary Outcome Measures

  1. To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence. [7 years]

  2. To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers [7 years]

  3. To assess time from positive ctDNA to clinical recurrence [7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

  4. Stage II patients must be microsatellite stable (MSS) and/or mismatch repair (MMR)-proficient.

  5. Stage III patients are eligible regardless of microsatellite instability (MSI) or MMR status.

  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

  7. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Providence Facey Medical Foundation Mission Hills California United States 91345
2 University of Florida Gainesville Florida United States 32610
3 Mount Sinai Medical - Comprehensive Cancer Center Miami Beach Florida United States 33140
4 Mid Florida Hematology and Oncology Center Orange City Florida United States 32763
5 Illinois Cancer Care Peoria Illinois United States 61615
6 Mercy Medical Center Cedar Rapids Iowa United States 52403
7 Medstar Franklin Square Baltimore Maryland United States 21237
8 Medstar Good Samaritan Baltimore Maryland United States 21239
9 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
10 University of Maryland St. Joseph Medical Center Towson Maryland United States 21093
11 MMCORC - Metro Minnesota Saint Louis Park Minnesota United States 55426
12 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
13 First Health of the Carolinas Cancer Center Pinehurst North Carolina United States 28374
14 Columbus Columbus Ohio United States 43215
15 Kaiser Permanente Northwest Portland Oregon United States 97227
16 Reading Hospital West Reading Pennsylvania United States 19611
17 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
18 WellSpan Health/York Cancer Center York Pennsylvania United States 17403
19 Primsa health Cancer Institute - Butternut Greenville South Carolina United States 29605
20 Ballad Health Cancer Care-Kingsport Kingsport Tennessee United States 37660
21 Marshfield Medical Center Weston Weston Wisconsin United States 54476

Sponsors and Collaborators

  • Exact Sciences Corporation
  • NSABP Foundation Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT05210283
Other Study ID Numbers:
  • 16-002
First Posted:
Jan 27, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Exact Sciences Corporation
Colorectal
ctDNA
Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm, Residual

Study Results

No Results Posted as of Jul 15, 2022