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Recruiting NCT02328677

ColoCare Study - Colorectal Cancer Cohort

— Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

Overview

ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).

Detailed description

The ColoCare Study 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 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).

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 sub-studies or in studies for older cancer patients. Recruitment of patients \>70 years was re-initiated after 06/2024 in anticipation of R01 grant funding.

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 (early-onset 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.

Primary outcome measures

  • Disease-free and overall survival [Time frame: up to 10 years]
  • Recurrence [Time frame: up to 5 years]
Secondary outcome measures (2)
  • Health-related quality of life [Time frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment]
  • Treatment toxicities [Time frame: up to 5 years post treatment]

Eligibility criteria

Inclusion criteria

  • Age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years. Recruitment of patients 70 years and older was maintained for specific sub-studies and re-initiated for specific R01 grant funding in \~06/2024
  • Men and women
  • Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)
  • English (FHCRC, Moffitt, HCI, Cedars-Sinai, WashU St. Louis) or German (University Hospital Heidelberg)-speaking;
  • mentally/physically able to consent and participate.

Exclusion criteria

  • if one of the above in not fulfilled
  • insufficient language or consent capacity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • Cedars-Sinai Medical Center — Los Angeles
  • Lee H. Moffitt Cancer Center — Tampa
  • Washington University School of Medicine — St Louis
  • University of Tennessee — Knoxville
  • Huntsman Cancer Institute — Salt Lake City
  • FHCRC — Seattle
Germany · 1 center
  • University Hospital Heidelberg — Heidelberg

Publications

  • Himbert C, Delphan M, Scherer D, Bowers LW, Hursting S, Ulrich CM. Signals from the Adipose Microenvironment and the Obesity-Cancer Link-A Systematic Review. Cancer Prev Res (Phila). 2017 Sep;10(9):494-506. doi: 10.1158/1940-6207.CAPR-16-0322. PMID 28864539
  • Ulrich CM, Himbert C, Holowatyj AN, Hursting SD. Energy balance and gastrointestinal cancer: risk, interventions, outcomes and mechanisms. Nat Rev Gastroenterol Hepatol. 2018 Nov;15(11):683-698. doi: 10.1038/s41575-018-0053-2. PMID 30158569
  • Zhang P, Holowatyj AN, Roy T, Pronovost SM, Marchetti M, Liu H, Ulrich CM, Edgar BA. An SH3PX1-Dependent Endocytosis-Autophagy Network Restrains Intestinal Stem Cell Proliferation by Counteracting EGFR-ERK Signaling. Dev Cell. 2019 May 20;49(4):574-589.e5. doi: 10.1016/j.devcel.2019.03.029. Epub 2019 Apr 18. PMID 31006650
  • Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimaki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, M PMID 31155658
  • Playdon MC, Joshi AD, Tabung FK, Cheng S, Henglin M, Kim A, Lin T, van Roekel EH, Huang J, Krumsiek J, Wang Y, Mathe E, Temprosa M, Moore S, Chawes B, Eliassen AH, Gsur A, Gunter MJ, Harada S, Langenberg C, Oresic M, Perng W, Seow WJ, Zeleznik OA. Metabolomics Analytics Workflow for Epidemiological Research: Perspectives from the Consortium of Metabolomics Studies (COMETS). Metabolites. 2019 Jul 1 PMID 31319517
  • Holowatyj AN, Lewis MA, Pannier ST, Kirchhoff AC, Hardikar S, Figueiredo JC, Huang LC, Shibata D, Schmit SL, Ulrich CM. Clinicopathologic and Racial/Ethnic Differences of Colorectal Cancer Among Adolescents and Young Adults. Clin Transl Gastroenterol. 2019 Jul;10(7):e00059. doi: 10.14309/ctg.0000000000000059. PMID 31259751
  • Zhang P, Holowatyj AN, Ulrich CM, Edgar BA. Tumor suppressive autophagy in intestinal stem cells controls gut homeostasis. Autophagy. 2019 Sep;15(9):1668-1670. doi: 10.1080/15548627.2019.1633863. Epub 2019 Jun 20. PMID 31213134
  • Simon LH, Saviers-Steiger C, Dunston ER, Galyean P, Kimball ER, Mendez J, Zickmund SL, Hansen PA, Ulrich CM, LaStayo PC, Steinberg D, Noren CS, Finch A, Seckinger L, Braun E, Chipman J, Brownson KE, Oza S, Coletta AM. Feasibility and acceptability of the Comprehensive Oncology Rehabilitation and Exercise (CORE) clinical workflow algorithm in patients with newly diagnosed stage I-III breast cancer PMID 40289623

Identifiers

NCT: NCT02328677 · 6407

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗