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

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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 200000 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015
Groups and Cohorts

Group/Cohort
Type 2 diabetes
Prediabetes
Normal glucose regulation


Outcome Measures

Primary Outcome Measures :
  1. number of participants who develop cancer during follow-up [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood and urine samples were collected and retained for biomarker analysis

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01506869     History of Changes
Other Study ID Numbers: CCEMD010
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012