Spots Global Cancer Trial Database for ColoCare Study - Colorectal Cancer Cohort
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Trial Identification
Brief Title: ColoCare Study - Colorectal Cancer Cohort
Official Title: ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis
Study ID: NCT02328677
Conditions
Interventions
Study Description
Brief Summary: ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).
Detailed Description: The ColoCare Consortium is a multicenter initiative establishing an international cohort of colorectal cancer (CRC) patients for interdisciplinary studies of CRC prognosis and outcomes with sites at the Fred Hutchinson Cancer Research Center, Seattle (Washington, USA), H. Lee Moffitt Cancer Center and Research Institute, Tampa (Florida, USA), the University Hospital Heidelberg (Germany), the Huntsman Cancer Institute (Utah, USA), the Cedars-Senai Medical Center (California, USA), University of Washington St. Louis (Missouri, USA), and University of Tennessee (Tennessee, USA). Additional information is provided in the study design paper, that has been published in 2019 (https://pubmed.ncbi.nlm.nih.gov/30523039/). Aims: The ColoCare Study investigates clinical outcomes, including disease-free and overall survival, predictors of cancer recurrence, survival, health-related quality-of-life and treatment toxicities. In addition, cross-sectional analyses of biomarkers and/or health behaviors are undertaken. Patients will be recruited if their age range is 18-89 years. For patients recruited after 09/01/2021 the age range is between 18-69 years, except if they participate in specific pilot studies. Patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of specimens and data. For the U01 renewal phase (start September 2021) we specifically focus on the recruitment of minorities (young patients, African American patients, Hispanic patients) and patients with rectal cancer. Furthermore, we will have an overall focus on questionnaire assessment at baseline, 12, and 60 months and intensive medical chart abstraction 24 months and 60. months after enrollment into the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
Lee H. Moffitt Cancer Center, Tampa, Florida, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Tennessee, Knoxville, Tennessee, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
FHCRC, Seattle, Washington, United States
University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany
Contact Details
Name: Cornelia M Ulrich, MS, PhD
Affiliation: Huntsman Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: William Grady, MD, PhD
Affiliation: Fred Hutchinson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Martin Schneider, MD
Affiliation: University Hospital Heidelberg
Role: PRINCIPAL_INVESTIGATOR
Name: Christopher Li, MD
Affiliation: Fred Hutchinson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Erin Siegel, PhD
Affiliation: Lee H. Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jane Figueiredo, PhD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: David Shibata, MD
Affiliation: University of Tennesee
Role: PRINCIPAL_INVESTIGATOR
Name: Adetunji T. Toriola, MD, PhD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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