Risk Evaluation of cAncers in Chinese diabeTic Individuals: a lONgitudinal Study (REACTION)
|ClinicalTrials.gov Identifier: NCT01506869|
Recruitment Status : Unknown
Verified January 2012 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : January 10, 2012
Last Update Posted : January 10, 2012
Phase 1: Baseline investigation (nation-wide survey)
Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all sites as well as for specific type of cancer, such as breast and colorectal cancer.
Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions (northeast, north, east, south central, northwest, and southwest China), degrees of urbanization (large cities [Beijing, Shanghai, and provincial capitals], midsize cities, county seats, and rural townships), and economic development status (as assessed on the basis of the gross domestic product [GDP] for each province). A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes and prediabetes should be diagnosed by OGTT according to the WHO 1999 criteria, while the diagnosis of cancer is established on the self-report questionnaire and cross checking with the tumor registry or a proof of doctor's diagnosis.
Phase 2: Cohort follow-up
Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal glucose regulation (NGR).
Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||June 2015|
|Type 2 diabetes|
|Normal glucose regulation|
- number of participants who develop cancer during follow-up [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506869
|Contact: Guang Ning, MD,PHD||008621 64370045 ext firstname.lastname@example.org|
|Shanghai Jiao-Tong University School of Medicine||Recruiting|
|Shanghai, China, 200025|
|Contact: Guang Ning, MD,PHD 008621 64370045 ext 663340 email@example.com|
|Principal Investigator:||Guang Ning, MD,PHD||Shanghai Jiao Tong University School of Medicine|