NCT02216955

Brief Summary

China has the largest gastric cancer patients population all over the world. Recent reports concluded nutrition status and lifestyle factors were associated with gastric cancer risk, however, the influence of nutrition and lifestyle factors on cancer outcome in gastric 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 gastric 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 gastric cancer of China, and the improvement of the quality of clinical management of patients with gastric cancer.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

11.9 years

First QC Date

August 13, 2014

Last Update Submit

February 18, 2018

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-specific survival

    Disease-specific survival is defined as the time elapsed from surgery to death due to gastric cancer. 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 Outcomes (1)

  • Overall survival

    7 years

Other Outcomes (1)

  • Disease-free survival

    7 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patient must have a histologically proven adenocarcinoma of gastric 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.

You may not qualify if:

  • 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..
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key laboratory of Cancer Biology

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Dake Chu, M.D.

CONTACT

chudake@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2020

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

CN(1)