Risk Evaluation of cAncers in Chinese diabeTic Individuals: a lONgitudinal Study

Cancer Clinical Trial

— REACTION  

Official title:

A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01506869
• Other study ID #: CCEMD010
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 9, 2012
• Start date: May 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Guang Ning, MD,PHD
• Phone: 008621 64370045
• Email: guangning[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Phase 1

Inclusion Criteria:

1. Age >= 40 years old

2. Gender: males and females

3. Provide written informed consent

4. Satisfactory compliance

Phase 2

Inclusion Criteria:

1. Age >= 40 and =< 75 years old

2. Gender: males and females

3. Provide written informed consent

4. Satisfactory compliance

Exclusion Criteria:

1. History of cancer;

2. History of LADA and other autoimmunity diseases;

3. Acute diabetic complication, acidosis, etc;

4. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;

5. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
China	Shanghai Jiao-Tong University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Chinese Society of Endocrinology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants who develop cancer during follow-up		3 years	No