Epidemiologic Study Of Diabetes And Cancer Risk

NCT ID: NCT02958995

Last Updated: 2018-03-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2738161 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-01

Study Completion Date

2015-05-29

Brief Summary

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The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes along with the assessment of association between diabetes severity and cancer risk.

Detailed Description

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The study enroll a large population of approximately 252467 participants. This epidemiology study of diabetes and cancer risk is an expansion study which would include estimation of cancer rate among KPNC members with or without diabetes and the relative risks of cancers associated with a diagnosis of diabetes. The study included diabetes participants who were KPNC members between 1997 and 2011. It also included a subset of participants who took the 1996/7 diabetes survey and Member Health Survey (MHS) in 1993, 1999, 2001 or 2003.

This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. The participants were followed-up from January 1, 1997 up to December 31, 2011.

Conditions

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Diabetes Mellitus, Type 2, Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Full KPNC Cohort

Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.

No Intervention

Intervention Type OTHER

Survey Responders

A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.

No Intervention

Intervention Type OTHER

Interventions

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No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: 1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997 and had no prior diagnosis of the cancer of interest.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

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EUPAS10335

Identifier Type: REGISTRY

Identifier Source: secondary_id

AD-4833_403B

Identifier Type: -

Identifier Source: org_study_id

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