Clinical Trial 16028

• Overview

  Study Title:

  Transdisciplinary Research in Colorectal Cancer: The ColoCare Study

  Summary:

  This is a research study of colorectal cancer. Our long-term goals are to learn how to improve treatment success in future patients and what future patients can do to improve their health after diagnosis. For example, testing may be done to find new ways to tailor therapy, or to evaluate a patient's health status after a colorectal cancer diagnosis.

  Objective:

  This study will establish a cohort of 5000 colorectal cancer patients across the ColoCare Study international and national sites. We will establish a cohort of colorectal cancer patients with a comprehensive assessment of quality of life, health behaviors, medical history and clinical outcomes (treatment, surgery, recurrence), at baseline (surgery) and during follow-up (3, 6, 12, 24, 36, 48, and 60 months). Blood samples will be collected at baseline, 6 month, and annually thereafter for biomarker assays. Study participants will also be asked to provide urine, saliva, tumor & adjacent normal tissue, subcutaneous and visceral adipose tissue, and fecal (=stool) samples. The patient can opt out of specific collections if they wish to do so. We will molecularly characterize the tumors of the cohort members using multiple state of the art approaches, including but not limited to DNA methylation, gene expression, microsatellite instability (MSI), DNA sequencing, immune profiling, and/or microbiome measurement.

• Inclusion Criteria

  > 18 years of age or older
  • newly-diagnosed Stage I-IV colorectal cancer
  • no previous chemotherapy, radiation or surgical treatment

• Exclusion Criteria

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