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

• Conditions: Cancer

• Registration Number: NCT01506869
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Status Verified: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Study First Posted: 2012-01-10
• Last Update Posted: 2012-01-10
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of participants who develop cancer during follow-up	3 years

Trial Locations

Locations (1)

Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, China