Nutrition and Lifestyle Study Cohort of Colorectal Cancer in China
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|ClinicalTrials.gov Identifier: NCT02215642|
Recruitment Status : Recruiting
First Posted : August 13, 2014
Last Update Posted : February 20, 2018
|Condition or disease|
Background - Colorectal cancer incidence is increasing at an alarming rate in China. Recent studies reported that nutrition status and lifestyle factors such as dietary pattern, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement were associated cancer risk. Yet, the influence of nutrition and lifestyle factors on colorectal cancer outcome (i.e. recurrence and survival) in colorectal cancer survivors is largely unknown. And there is currently no large cohort studies investigated the impact of these factors on colorectal cancer outcomes in China.
Objectives - Our study aims to evaluate the impact of nutrition status and lifestyle factors such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement on colorectal cancer outcome (disease-specific survival, disease-free survival and overall survival).
Settings and methods - The study will recruit approximately 50,000 participants with colorectal cancer from 12 public hospitals in China after informed consent. Appropriate questionnaires will be utilized to evaluate nutrition status and lifestyle factors such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement. The association of disease-specific survival, disease-free survival and overall survival with these factors will be evaluated.
Impact - To the best of our knowledge, this is the first large cohort, systematically investigation of the impact of nutrition status and lifestyle factors on colorectal cancer outcome. When complete, our investigation would supply a systematical and precise understanding of the impact nutrition status and lifestyle factors on cancer out come in China.
|Study Type :||Observational|
|Estimated Enrollment :||50000 participants|
|Official Title:||Impact of Nutrition, Dietary Pattern, Obesity, Physical Activity, Depression, Diabetes, Aspirin Use and Vitamin Supplement in Colorectal Cancer in China|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2020|
- Disease-specific survival [ Time Frame: 7 years ]Disease-specific survival is defined as the time elapsed from surgery to death due to CRC. Concretely, the cause of death obtained in the follow up was classified according to ICD-10 conventions. Disease-specific deaths included those with an underlying cause attributed to ICD-10 codes C18.0-C20.0 or C26.0.
- Overall survival [ Time Frame: 7 years ]Overall survival is defined as the time elapsed from surgery to the date of death from any cause.
- Disease-free survival [ Time Frame: 7 years ]Disease-free survival is defined as the time elapsed from surgery to the first occurrence of any of the following events: recurrence of colorectal cancer; colorectal cancer distant metastasis; development of second non-colorectal malignancy excluding basal cell carcinomas of the skin and carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215642
|Contact: Dake Chu, M.D.||firstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710032|
|Contact: Dake Chu, M.D. email@example.com|
|Principal Investigator:||Dake Chu, M.D.||Fourth Military Medical University|