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The ColoCare Study
Trial Status: active
This study identifies factors that determine both short-term and long-term survival in a prospective cohort of colorectal cancer patients. Information collected in this study may help doctors to learn how to improve treatment success in future patients by tailoring therapies to each patient’s unique biology, and what future patients can do to improve their health after diagnosis.
Inclusion Criteria
Ages 18-89 at the time of diagnosis
Newly-diagnosed or recurring colorectal cancer (any stage)
Diagnosed by, consulting with, and/or receiving surgery or other cancer treatment from a physician participating in the ColoCare study
Residing in any state in the United States (U.S.)
Exclusion Criteria
Women pregnant at the time of diagnosis, prisoners, and patients unable to provide informed consent, or unable to read, write, or fill in questionnaires in English will not be included in this study. In the future, Spanish speaking people may be included in the study, once study-approved documents are translated in Spanish
After patient enrollment, if any participants develop a mental impairment that does not allow the participant to complete study procedures (per judgment by study staff), they will not be contacted any further for study procedures
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02328677.
I. To identify factors that determine both short-term and long-term survival in a prospective cohort of colorectal cancer patients.
OUTLINE:
Patients complete questionnaires at baseline, 3 and 6 months post-surgery (or start of chemotherapy or radiation treatments), and then spaced at 6 to 12 month intervals after surgery (or chemotherapy or radiation treatments) for up to 6 years after surgery, treatment, or consent date. Patients who enrolled in the study approximately 12 months or longer complete a one-time employment and financial supplement survey. Patients may undergo collection of blood samples at 6 months and 12 months post-surgery, and then once a year for up to 6 years; collection of urine, saliva, and stool samples before neoadjuvant therapy (if applicable) and before colorectal cancer surgery, 6 months, 12 months, and annually thereafter; and collection of tumor and adjacent normal tissue, subcutaneous and visceral adipose tissue samples during standard of care surgery (if applicable). Patients may wear accelerometer to monitor daily physical activity and participate in a physical fitness assessment over 30 minutes at 12, 24, and 36 months. Patients' medical records are reviewed.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationHuntsman Cancer Institute/University of Utah
