CancerREACTIONNCT01506869
Risk Evaluation of cAncers in Chinese diabeTic Individuals: a lONgitudinal Study
An observational study of Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age >= 40 years old
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
- Phase 2
- Age >= 40 and =< 75 years old
Show all 9Show fewer
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
Who cannot join
- History of cancer;
- History of LADA and other autoimmunity diseases;
- Acute diabetic complication, acidosis, etc;
- Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
- Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao-Tong University School of Medicine
Shanghai, 200025
Guang Ning, MD,PHD, 008621 64370045 ext. 663340, guangning@medmail.com.cn
About this study
Official title: A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women
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.
Read more
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Not described | |
| Prediabetes | Not described | |
| Normal glucose regulation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who develop cancer during follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Society of Endocrinology
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD,PHD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506869
- Sponsor's protocol ID
- CCEMD010
- Acronym
- REACTION
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu Y, Li B, Lin L, Chen K, Zhang B, Wang W, Gu W, Shen J, Mu Y. The association between triglyceride glucose index and changes in carotid intima-media thickness: a 6-year prospective study in the 4C cohort. Endocrine. 2026 Mar 9;91(1):90. doi: 10.1007/s12020-025-04500-8.
PubMed 41801510Wang L, Wu P, Chen K, Li B, Wang J, Mu Y. Correlation between rate-pressure product or pressure-rate quotient and urinary albumin-creatinine ratio in the Chinese older population: The REACTION study. Chin Med J (Engl). 2024 Jan 20;137(2):238-240. doi: 10.1097/CM9.0000000000002941. Epub 2024 Jan 8. No abstract available.
PubMed 38185831Xu C, Zhou G, Zhao M, Zhang X, Fang L, Guan Q, Zhang H, Gao L, Zhang T, Zhao J. Bidirectional temporal relationship between obesity and hyperinsulinemia: longitudinal observation from a Chinese cohort. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e002059. doi: 10.1136/bmjdrc-2020-002059.
PubMed 33632707Chen Y, Lin H, Qin L, Lu Y, Zhao L, Xia M, Jiang J, Li X, Yu C, Zong G, Zheng Y, Gao X, Su Q, Li X. Fasting Serum Fructose Levels Are Associated With Risk of Incident Type 2 Diabetes in Middle-Aged and Older Chinese Population. Diabetes Care. 2020 Sep;43(9):2217-2225. doi: 10.2337/dc19-2494. Epub 2020 Jul 1.
PubMed 32611608
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women
- ClinicalTrials.gov ID
- NCT01506869
- Acronym / sponsor ID
- REACTION / CCEMD010
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Chinese Society of Endocrinology
- Study start
- May 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | – |
| Prediabetes | – | – |
| Normal glucose regulation | – | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- Age >= 40 years old
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
- Phase 2
Key exclusion criteria (5 listed)
- History of cancer;
- History of LADA and other autoimmunity diseases;
- Acute diabetic complication, acidosis, etc;
- Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
- Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of participants who develop cancer during follow-up
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
- Derived from this study: PubMed 41801510Liu Y, Li B, Lin L, Chen K, Zhang B, Wang W, Gu W, Shen J, Mu Y. The association between triglyceride glucose index and changes in carotid intima-media thickness: a 6-year prospective study in the 4C cohort. Endocrine. 2026 Mar 9;91(1):90. doi: 10.1007/s12020-025-04500-8.
- Derived from this study: PubMed 38185831Wang L, Wu P, Chen K, Li B, Wang J, Mu Y. Correlation between rate-pressure product or pressure-rate quotient and urinary albumin-creatinine ratio in the Chinese older population: The REACTION study. Chin Med J (Engl). 2024 Jan 20;137(2):238-240. doi: 10.1097/CM9.0000000000002941. Epub 2024 Jan 8. No abstract available.
- Derived from this study: PubMed 33632707Xu C, Zhou G, Zhao M, Zhang X, Fang L, Guan Q, Zhang H, Gao L, Zhang T, Zhao J. Bidirectional temporal relationship between obesity and hyperinsulinemia: longitudinal observation from a Chinese cohort. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e002059. doi: 10.1136/bmjdrc-2020-002059.
- Derived from this study: PubMed 32611608Chen Y, Lin H, Qin L, Lu Y, Zhao L, Xia M, Jiang J, Li X, Yu C, Zong G, Zheng Y, Gao X, Su Q, Li X. Fasting Serum Fructose Levels Are Associated With Risk of Incident Type 2 Diabetes in Middle-Aged and Older Chinese Population. Diabetes Care. 2020 Sep;43(9):2217-2225. doi: 10.2337/dc19-2494. Epub 2020 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD,PHD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, MD,PHD (008621 64370045 ext. 663340, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who develop cancer during follow-up (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506869, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2012.