Today’s cancer patients benefit from the knowledge gained through studies done before, just as future patients may benefit from what we learn now.
The ColoCare Study
The ColoCare Study (NCT02328677) is a prospective cohort of men and women diagnosed with primary invasive colorectal cancer (stages I-IV). The study aims to collect information on primary outcomes, including quality of life, recurrence, and overall survival.
This is the only colorectal cancer cohort that includes the collection of clinical and risk factor data and the sampling of a diverse panel of biospecimens at multiple time points from surgery through survivorship.
This unique design with repeat assessments enables this innovative research:
- Influence of lifestyle or behavioral factors on patient health and outcomes.
- Ethnic/racial or rural/urban disparities in clinical outcomes.
- Discovery of novel biomarkers from blood, urine, and stool to guide treatment decision-making and risk prediction.
- Interactions between treatment, risk factors, and biomarkers on clinical outcomes.
ColoCare Study Goals
The goal of this study is to collect data and biospecimens from more than 5,000 multiethnic colorectal cancer patients at multiple time points, including detailed treatment and risk factor data; fresh and fixed tumor and normal tissue; visceral adipose and subcutaneous tissue; and blood, stool, urine, saliva, and quantitative accelerometry data to assess physical activity.
Depending on the ColoCare Study implementation, data and biospecimens are available on subsets of the population. Please read our study design paper for more information. We have also recently published some characteristics of the study population as part of an investigation of early-onset colorectal cancer.
Each ColoCare Study site leverages existing infrastructure, including access to electronic medical records and NCI cancer center cores, while using standardized protocols for recruitment, data collection, and biospecimen ascertainment that are consistently applied across all sites.
Patients follow up both actively and passively with study staff (in-person and through medical record reviews), as well as via linkages to cancer registry and vital status records.
ColoCare has successfully launched research in several areas:
- Health behaviors such as physical activity, nutrition, and dietary supplement use
- Biomarkers such as inflammatory and angiogenesis biomarkers, metabolomics, and the gut microbiome
- Risk factors such as obesity, diet, and comorbidities
- Clinical endpoints such as quality of life and surgical complications, as well as interrelations between these factors in the context of colorectal cancer prognosis
Some of our current research focuses on understudied and under deserved populations.
Early-onset colorectal cancer
Over the past several decades, colorectal cancer (CRC) incidence and mortality rates have declined among older adults (≥50 years). Alarmingly, however, since the 1990s there has been a significant increase in early-onset CRC (EOCRC; patients younger than 50 years at diagnosis) especially in the US and Western countries. The drivers or risk factors of this rapid increase in EOCRC remain poorly understood. Further, EOCRC patients are more likely to experience long-lasting treatment side effects, experience reproductive concerns, as well as poor clinical outcomes. Thus, there is a need for a comprehensive, prospective, and highly annotated cohort of patients with colorectal cancer to find answers in this important area. Researchers at Huntsman Cancer Institute are trying to better understand EOCRC through the ColoCare Study, one of the few resources to address these highly relevant research questions. For example, one recently published study showed that patients with EOCRC were more likely to be diagnosed with advanced stage disease, to have received systemic treatments regardless of stage at diagnosis, and were less likely to be ever smokers or overweight. In addition, we have shown that oxidative stress may be a central driver for EOCRC.
Contrary to the high incidence and mortality rates of colon cancer, rectal cancer incidence is lower and still represents an understudied disease. Currently, the treatment options for locally advanced (stage II/III) rectal cancer are in the midst of change. Most notable has been the re-sequencing of adjuvant chemotherapy to the pre-operative setting (termed total neoadjuvant therapy or TNT). This new approach has been incorporated as a standard option in national guidelines. There is also a growing adoption of selective non-operative management i.e., “watch and wait” for stage II/III rectal cancer patients experiencing a complete clinical response to neoadjuvant therapy. These new paradigms are resulting in changes in the nature and severity of different patient-centered and oncologic outcomes that will alter the significance of clinical predictors and biomarkers of treatment response and outcomes Studies conducted as part of the ColoCare Study, aim to investigate the impact of these recently introduced treatment regimens (related to the application of total neoadjuvant therapy and non-operative management) on treatment response, outcomes, and prognosis and aim to develop new biomarkers among rectal cancer patients.
Colorectal cancer disparities
CRC is a common cancer with significant, unresolved disparities across race/ethnicity and rural/urban residency. Medically underserved and understudied CRC patients in the U.S. continue to experience higher burdens of cancer recurrence, mortality, and other cancer-related outcomes. Further, in the U.S., non-Hispanic (NH)-Blacks/African Americans experience the lowest CRC-specific 5-year survival rates followed by NH-Whites, Hispanics/Latinos, and Asians/Pacific Islanders. A recent spotlight on rural disparities in cancer outcomes has raised the urban-rural divide in cancer to an issue of critical importance nationally, with unique challenges facing rural populations that require targeted research. Thus, research aimed at mitigating CRC disparities in these underserved populations is of pressing importance. Studies within the ColoCare Study, aim to investigate biological determinants of outcomes across ethnic/racial populations, financial toxicities and access to care across geographically, and ethnically/racially diverse populations, quality of life changes over the survivorship trajectory across diverse populations.
We would like to thank all the sponsors that have provided funding for various aspects of this international study. Examples of funding include:
- National Cancer Institute
- U01 CA206110, “Transdisciplinary Team Science in Colorectal Cancer Prognosis: the ColoCare Study”
- U01 CA152756, “Biomarkers for Reducing Mortality of Cancers of the Colon and Esophagus”
- R01 CA189184, “Discovery and verification of novel biomarkers of colorectal cancer recurrence”
- R01 CA207371, “Metabolomic Strategies for Discovery and Validation of Biomarkers of Colorectal Cancer Recurrence”
- R01 CA194663, “(PQC1) Accelerated biological aging and colon polyp to cancer progression”
- R01 CA220004, “(PQ6) Radiogenomics of colorectal polyps to assess benign proliferative vs. premalignant states.”
- P30 CA042014, “Cancer Center Support Grant” (Huntsman Cancer Institute)
- P30 CA015704, “Cancer Center Support Grant” (Fred Hutchinson Cancer Research Center)
- P30 CA076292, “Cancer Center Support Grant” (Moffitt Cancer Center)
- P30 CA091842, “Center for Biomedical Informatics” (Washington University, St. Louis)
- P30 CA091842, “Cancer Center Support Grant” (Washington University, St. Louis)
- Huntsman Cancer Foundation, Salt Lake City, UT
- The Seattle Translational Tumor Research Program, and the Cottrell Family
- Florida Department of Health Bankhead Coley New Investigator Award and the National Cancer Institute projects
- Institutional funding from the German Cancer Research Center (DKFZ), Heidelberg, Germany to the Division of Preventive Oncology at the National Center for Tumor Diseases (NCT), Heidelberg, Germany
- Matthias Lackas Foundation, Heidelberg, Germany
- Stiftung Lebensblicke, Hamburg, Germany
- ERA-NET on Translational Cancer Research (project no. 01KT1512)
- ERA-NET on Translational Cancer Research (TRANSCAN) project 01KT1503
- ColoCare Moffitt has been supported in part by the Tissue Core Facility and the Survey Methods Core at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center