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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Collaborator:
Chinese Society of Endocrinology
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01506869
First received: January 5, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • number of participants who develop cancer during follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and urine samples were collected and retained for biomarker analysis


Estimated Enrollment: 200000
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 diabetes
Prediabetes
Normal glucose regulation

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In phase 1, 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions, degrees of urbanization, and economic development status In Phase 2, 30,000-40,000 type 2 diabetes, 20,000-30,000 prediabetes, 30,000-40,000 normal glucose regulation, recruited from the baseline survey

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506869

Contacts
Contact: Guang Ning, MD,PHD 008621 64370045 ext 663340 guangning@medmail.com.cn

Locations
China
Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Guang Ning, MD,PHD    008621 64370045 ext 663340    guangning@medmail.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Chinese Society of Endocrinology
Investigators
Principal Investigator: Guang Ning, MD,PHD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01506869     History of Changes
Other Study ID Numbers: CCEMD010
Study First Received: January 5, 2012
Last Updated: January 9, 2012
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on July 22, 2014