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临床试验/NCT02328677
NCT02328677招募中不适用

ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis

University of Utah7 个研究点 分布在 2 个国家目标入组 5,000 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
7
主要终点
Recurrence

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Recurrence

时间窗: up to 5 years

Disease-free and overall survival

时间窗: up to 10 years

次要结局

  • Treatment toxicities(up to 5 years post treatment)
  • Health-related quality of life(at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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