Colorectal cancer will affect one in 20 individuals over the course of their lifetime. The ColoCare Study is a prospective cohort of men and women newly diagnosed with a first primary invasive colorectal cancer (stage I-IV) with repeat data and biospecimen collection beginning prior to surgery. The ColoCare Study was initiated at the Fred Hutchinson Cancer Research Center with subsequent consortium sites at the Moffitt Cancer Center, the German Cancer Research Center, and Huntsman Cancer Institute with institutional pilot/start-up funding to support patient recruitment. The goal of this study is to uniformly collet comprehensive sets of data and biospecimens from over 4000 multiethnic colorectal cancer patients at multiple time points (prior to surgery and 3, 6, 12, 24, 36, 48 and 60 months post-surgery), including detailed treatment and risk factor data, fresh and fixed tumor and normal tissue, visceral adipose tissue, blood, stool, urine, saliva, and quantitative accelerometry data t assess physical activity. Each ColoCare Study site leverages existing infrastructure, including access to electronic medical records and NCI comprehensive/designated cancer center cores, while utilizing well-established protocols for recruitment, data collection, and biospecimen ascertainment that are consistently applied across all sites. Patients are followed up both actively and passively by study staff (in-person and through medical record reviews), as well as via linkages to cancer registry and vital status records. Currently, using pilot/institutional fund at four existing sites, we have recruited >1100 patients (n=1010 baseline bloods). With this infrastructure grant, we propose 1) to extend the ColoCare consortium to two new study centers that will enrich our numbers of underrepresented minority participants (University of Southern California, LA, and Washington University School of Medicine, St. Louis) and 2) to continue and expand study procedures at all US sites, including energy balance assessments and molecular characterization of tumors. The support for expanded enrollment and continued follow-up of the ColoCare cohort will result in an estimated 4167 highly characterized enrollees. The repeat sampling of data and a diverse set of accompanying biospecimens at critical time points enables unprecedented epidemiologic and biomarker research that can inform clinical decision making and support evidence-based guidelines regarding lifestyle changes that impact outcomes. Additionally, we will establish an external advisory board and a community/participant advisory board to further guide infrastructure development and prioritize research use of this cohort. We will continue to participate in national and international consorti by contributing data and biospecimens. Support for this unique cohort of colorectal cancer patients will create a valuable resource for the broader research community. In-depth, repeated phenotyping within a single cohort will enable one-of-a-kind studies focused on the effects of health behaviors on prognosis, as well as the discovery of new biomarkers of clinically important outcomes.

Public Health Relevance

We propose to continue building and expanding the ColoCare Study, the only existing cohort of colorectal cancer patients for whom clinical data, information on health behaviors, and universal biospecimens have been systematically collected at repeat time points; ColoCare is uniquely suited for the discovery of new biomarkers of colorectal cancer treatment response and prognosis, as well as research that elucidates the influence of health behaviors on treatment efficacy and toxicity, quality-of-life, recurrence, and survival. We propose here to continue and augment collections at existing ColoCare sites, expand to two new sites that will focus on the recruitment of ethnic/racial minorities (over 4000 participants), and perform molecular characterization of tumor samples. This unique, multiethnic cohort will be an incredible resource for the broader research community, given its suitability for a wide-range of studies with potentially significant and near-term clinical impact.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01CA206110-01
Application #
9107636
Study Section
Special Emphasis Panel (ZCA1-TCRB-Y (J2))
Program Officer
Elena, Joanne W
Project Start
2016-09-19
Project End
2021-08-31
Budget Start
2016-09-19
Budget End
2017-08-31
Support Year
1
Fiscal Year
2016
Total Cost
$1,862,336
Indirect Cost
$280,173
Name
University of Utah
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
Delphan, Mahmoud; Lin, Tengda; Liesenfeld, David B et al. (2018) Associations of branched-chain amino acids with parameters of energy balance and survival in colorectal cancer patients: Results from the ColoCare Study. Metabolomics 2018:
Himbert, Caroline; Ose, Jennifer; Nattenmüller, Johanna et al. (2018) Body fatness, adipose tissue compartments and biomarkers of inflammation and angiogenesis in colorectal cancer: the ColoCare Study. Cancer Epidemiol Biomarkers Prev :
Babaei, Masoud; Jansen, Lina; Balavarca, Yesilda et al. (2018) Neoadjuvant Therapy in Rectal Cancer Patients With Clinical Stage II to III Across European Countries: Variations and Outcomes. Clin Colorectal Cancer 17:e129-e142
Babaei, Masoud; Balavarca, Yesilda; Jansen, Lina et al. (2018) Administration of adjuvant chemotherapy for stage II-III colon cancer patients: An European population-based study. Int J Cancer 142:1480-1489
Gigic, Biljana; Boeing, Heiner; Toth, Reka et al. (2018) Associations Between Dietary Patterns and Longitudinal Quality of Life Changes in Colorectal Cancer Patients: The ColoCare Study. Nutr Cancer 70:51-60
Paleari, Laura; Burhenne, Jürgen; Weiss, Johanna et al. (2018) High Accumulation of Metformin in Colonic Tissue of Subjects With Diabetes or the Metabolic Syndrome. Gastroenterology 154:1543-1545
Neumeyer, Sonja; Banbury, Barbara L; Arndt, Volker et al. (2018) Mendelian randomisation study of age at menarche and age at menopause and the risk of colorectal cancer. Br J Cancer 118:1639-1647
Ozoya, Oluwatobi O; Siegel, Erin M; Srikumar, Thejal et al. (2017) Quantitative Assessment of Visceral Obesity and Postoperative Colon Cancer Outcomes. J Gastrointest Surg 21:534-542
Yuan, Zixu; Baker, Kelsey; Redman, Mary W et al. (2017) Dynamic plasma microRNAs are biomarkers for prognosis and early detection of recurrence in colorectal cancer. Br J Cancer 117:1202-1210
Barrow, Timothy M; Klett, Hagen; Toth, Reka et al. (2017) Smoking is associated with hypermethylation of the APC 1A promoter in colorectal cancer: the ColoCare Study. J Pathol 243:366-375

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