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CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
Northwest
Exact Sciences Corporation
 
Acronym KP IRB No.
(MRD) IRB00000971
 
Study Type Phase
Other Observational Study with Direct Patient Contact
 
Study Population Description
(Adult, Older Adult) Male and Female with Colorectal Cancer
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer
  • Histologic diagnosis of carcinoma of the colon or rectum
  • Undergone complete surgical resection of the primary tumor within 3 months prior to enrollment
  • Pathologic stage II or III * Stage II patients must be microsatellite stable (MSS) and/or mismatch repair (MMR)-proficient. * Stage III patients are eligible regardless of microsatellite instability (MSI) or MMR status
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • No clinical contraindication to adjuvant chemotherapy
 
Exclusion Criteria
  • Received prior systemic anti-cancer therapy
  • Pregnant or breastfeeding at time of enrollment
  • Prior history and treatment for any invasive cancer within the past 5 years, with the exception of non-melanoma skin cancer
  • 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
  • MMR deficient tumor or germline MMR deficiency (Lynch Syndrome) with Stage II colorectal cancer
  • Prior stem cell transplant

 
Keywords and/or Specific Medical Conditions
  • Colonic Diseases
  • Neoplasm, Residual
  • Colorectal Neoplasms
  • Neoplasms
  • Digestive System Diseases
  • Neoplasms by Site
  • Digestive System Neoplasms
  • Neoplastic Processes
  • Gastrointestinal Diseases
  • Pathologic Processes
  • Gastrointestinal Neoplasms
  • Rectal Diseases
  • Intestinal Diseases
  • Oncology (Adult)
  • Intestinal Neoplasms
  • Surgery (Vascular)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)
  • Surgery (Vascular)


Principal Investigator:
Sandeep Mashru, MD
Contact Information:
- Susan Granat
-503)335-2400
-Susan.J.Granat@kpchr.org
-Central Interstate Medical Office


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