Nutrition and Lifestyle Study Cohort of Colorectal Cancer in China

Impact of Nutrition, Dietary Pattern, Obesity, Physical Activity, Depression, Diabetes, Aspirin Use and Vitamin Supplement in Colorectal Cancer in China

Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports concluded nutrition status and lifestyle factors were associated with colorectal cancer risk, however, the influence of nutrition and lifestyle factors on cancer outcome in colorectal cancer survivors is largely unknown.The investigators will explore the impact of nutrition status, life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement on colorectal cancer outcome. The investigators will recruit approximately 50,000 patients as a prospective study cohort. During follow up, the investigators will explore the association of these factors with disease-specific survival, disease-free survival and overall survival of patients. The investigators believe that this project will facilitate the establishment of domestic nutrition and lifestyle data of colorectal cancer of China, and the improvement of the quality of clinical management of patients with colorectal cancer.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

Detailed Description

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
• Enrollment (Anticipated): 50000

Contacts and Locations

• Study Contact: Name: Dake Chu, M.D.; Email: chudake@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Dake Chu
      • Contact: Dake Chu, M.D.; Email: chudake@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators will recruit about 50,000 patients with colorectal cancer in 12 hospitals of China

Description

Inclusion Criteria:

• Patient must have a histologically proven adenocarcinoma of colon or rectum cancer.
• Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
• Patients must have recovered from any effects of surgery.
• Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
• Patients must provide a signed consent to participate in the study.
• Patients must complete all questionnaires.

Exclusion Criteria:

• Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
• History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
• Unresolved bacterial infection requiring treatment with antibiotics.
• Pregnant or lactating women may not participate in the study.
• Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
• Gilbert's disease.
• Other serious concurrent infection
• Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific survival	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.	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.	7 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	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.	7 years

Collaborators and Investigators

• Sponsor: State Key Laboratory of Cancer Biology
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; Third Military Medical University; Shanghai Jiao Tong University School of Medicine; China-Japan Friendship Hospital; Tang-Du Hospital; Second Military Medical University; Tianjin Union Medical Center; Beihua University; Chengdu Medical College

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: cdk-201001