Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT02958995
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Epidemiologic Study Of Diabetes And Cancer Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Due to the observational nature of study individual adverse events (AEs) were not planned to be collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Survey Responders Cohort', 'description': '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.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2630666', 'groupId': 'OG000'}, {'value': '107495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.'}, {'id': 'OG001', 'title': 'Survey Responders Cohort', 'description': '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.'}], 'classes': [{'title': 'Prostate, Diabetes Status: No', 'categories': [{'measurements': [{'value': '380.2', 'groupId': 'OG000', 'lowerLimit': '375.6', 'upperLimit': '384.9'}, {'value': '421.9', 'groupId': 'OG001', 'lowerLimit': '393.6', 'upperLimit': '450.2'}]}]}, {'title': 'Prostate, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '308.0', 'groupId': 'OG000', 'lowerLimit': '299', 'upperLimit': '316.9'}, {'value': '281.9', 'groupId': 'OG001', 'lowerLimit': '265.7', 'upperLimit': '298.2'}]}]}, {'title': 'Female Breast, Diabetes Status: No', 'categories': [{'measurements': [{'value': '291.8', 'groupId': 'OG000', 'lowerLimit': '288.2', 'upperLimit': '295.5'}, {'value': '310.7', 'groupId': 'OG001', 'lowerLimit': '287.6', 'upperLimit': '333.8'}]}]}, {'title': 'Female Breast, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '286.9', 'groupId': 'OG000', 'lowerLimit': '276.3', 'upperLimit': '297.5'}, {'value': '287.9', 'groupId': 'OG001', 'lowerLimit': '266.1', 'upperLimit': '309.6'}]}]}, {'title': 'Lung/Bronchus, Diabetes Status: No', 'categories': [{'measurements': [{'value': '111.3', 'groupId': 'OG000', 'lowerLimit': '109.7', 'upperLimit': '113.0'}, {'value': '116.1', 'groupId': 'OG001', 'lowerLimit': '107.0', 'upperLimit': '125.3'}]}]}, {'title': 'Lung/Bronchus, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '108.8', 'groupId': 'OG000', 'lowerLimit': '104.9', 'upperLimit': '112.6'}, {'value': '105.9', 'groupId': 'OG001', 'lowerLimit': '98.5', 'upperLimit': '113.2'}]}]}, {'title': 'Colon, Diabetes Status: No', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '70.5'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '67.9', 'upperLimit': '83.1'}]}]}, {'title': 'Colon, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '97.3'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '104.5'}]}]}, {'title': 'Non-Hodgkin lymphoma, Diabetes: No', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '40.5'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '46.6'}]}]}, {'title': 'Non-Hodgkin lymphoma, Diabetes: Yes', 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '48.4'}, {'value': '43.2', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '48.6'}]}]}, {'title': 'Corpus uteri, Diabetes Status: No', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '54.3', 'upperLimit': '57.5'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '49.6', 'upperLimit': '69.8'}]}]}, {'title': 'Corpus uteri, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '112.1', 'groupId': 'OG000', 'lowerLimit': '104.9', 'upperLimit': '119.2'}, {'value': '106.2', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '119.6'}]}]}, {'title': 'Pancreas, Diabetes Status: No', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '19.5'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '22.1'}]}]}, {'title': 'Pancreas, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '49.9'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '41.9'}]}]}, {'title': 'Kidney/Renal Pelvis, Diabetes Status: No', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '24.2'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '25.7'}]}]}, {'title': 'Kidney/Renal Pelvis, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '42.2'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '40.0'}]}]}, {'title': 'Rectal, Diabetes Status: No', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '25.4'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '31.7'}]}]}, {'title': 'Rectal, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '33.4'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '37.2'}]}]}, {'title': 'Melanoma, Diabetes Status: No', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': '43.5'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '48.5', 'upperLimit': '63.0'}]}]}, {'title': 'Melanoma, Diabetes Status: Yes', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '32.9'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '26.8', 'upperLimit': '36.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years', 'description': 'Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.', 'unitOfMeasure': 'Incidence per 100,000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.'}, {'type': 'PRIMARY', 'title': 'Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2630666', 'groupId': 'OG000'}, {'value': '107495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.'}, {'id': 'OG001', 'title': 'Survey Responders Cohort', 'description': '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.'}], 'classes': [{'title': 'Prostate, Diabetes Status', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.83'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '0.86'}]}]}, {'title': 'Female Breast, Diabetes Status', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.05'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.12'}]}]}, {'title': 'Lung/Bronchus, Diabetes Status', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.03'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.74', 'upperLimit': '0.96'}]}]}, {'title': 'Colon, Diabetes Status', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '1.42'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.38'}]}]}, {'title': 'Non-Hodgkin lymphoma, Diabetes', 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.21'}, {'value': '1.06', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '1.33'}]}]}, {'title': 'Corpus uteri, Diabetes Status', 'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '1.95'}, {'value': '1.67', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '2.18'}]}]}, {'title': 'Pancreas, Diabetes Status', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '2.35', 'upperLimit': '2.67'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '3.18'}]}]}, {'title': 'Kidney/Renal Pelvis, Diabetes Status', 'categories': [{'measurements': [{'value': '1.56', 'groupId': 'OG000', 'lowerLimit': '1.46', 'upperLimit': '1.67'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '1.82'}]}]}, {'title': 'Rectal, Diabetes Status', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.35'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.89'}]}]}, {'title': 'Melanoma, Diabetes Status', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '0.79'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '0.86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years', 'description': 'The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.'}, {'id': 'FG001', 'title': 'Survey Responders Cohort', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2630666'}, {'groupId': 'FG001', 'numSubjects': '107495'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2630666'}, {'groupId': 'FG001', 'numSubjects': '107495'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 2 investigative sites in the United States from 01 July 1997 to 30 June 2011.', 'preAssignmentDetails': 'Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2630666', 'groupId': 'BG000'}, {'value': '107495', 'groupId': 'BG001'}, {'value': '2738161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.'}, {'id': 'BG001', 'title': 'Survey Responders Cohort', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '40 - 49 years', 'categories': [{'measurements': [{'value': '1501084', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '30256', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '1531340', 'groupId': 'BG002'}]}]}, {'title': '50 - 59 years', 'categories': [{'measurements': [{'value': '570636', 'groupId': 'BG000'}, {'value': '24585', 'groupId': 'BG001'}, {'value': '595221', 'groupId': 'BG002'}]}]}, {'title': '60 - 69 years', 'categories': [{'measurements': [{'value': '322517', 'groupId': 'BG000'}, {'value': '25582', 'groupId': 'BG001'}, {'value': '348099', 'groupId': 'BG002'}]}]}, {'title': '70 - 79 years', 'categories': [{'measurements': [{'value': '170136', 'groupId': 'BG000'}, {'value': '22028', 'groupId': 'BG001'}, {'value': '192164', 'groupId': 'BG002'}]}]}, {'title': 'greater than or equal to (>=) 80 years', 'categories': [{'measurements': [{'value': '66293', 'groupId': 'BG000'}, {'value': '5044', 'groupId': 'BG001'}, {'value': '71337', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1353782', 'groupId': 'BG000'}, {'value': '54418', 'groupId': 'BG001'}, {'value': '1408200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1276884', 'groupId': 'BG000'}, {'value': '53077', 'groupId': 'BG001'}, {'value': '1329961', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1339805', 'groupId': 'BG000'}, {'value': '67837', 'groupId': 'BG001'}, {'value': '1407642', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '171604', 'groupId': 'BG000'}, {'value': '10167', 'groupId': 'BG001'}, {'value': '181771', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '322046', 'groupId': 'BG000'}, {'value': '11871', 'groupId': 'BG001'}, {'value': '333917', 'groupId': 'BG002'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '312730', 'groupId': 'BG000'}, {'value': '13508', 'groupId': 'BG001'}, {'value': '326238', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '87901', 'groupId': 'BG000'}, {'value': '2728', 'groupId': 'BG001'}, {'value': '90629', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '396580', 'groupId': 'BG000'}, {'value': '1384', 'groupId': 'BG001'}, {'value': '397964', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The observational study population consisted of T2DM participants who were identified from KPNC registry (with or without diabetes) and had completed the KPNC survey and MHS in the analysis.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2738161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-11-04', 'resultsFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-20', 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status', 'timeFrame': '15 years', 'description': 'Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.'}, {'measure': 'Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes', 'timeFrame': '15 years', 'description': 'The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Diabetes Mellitus, Type 2, Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.takeda.com/siteassets/en-us/home/external-reference/clinicaltrials.gov/ad-4833-403-fum_35.4_kpnc_interim_results_report-2011-12-07.pdf', 'label': 'Interim Results Report'}, {'url': 'https://www.takeda.com/siteassets/en-us/home/external-reference/clinicaltrials.gov/ad4833-403_kpnc_10_common_cancers_10-yr_study_report.pdf', 'label': '10 Yr Study Report'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT02958995', 'briefTitle': 'Epidemiologic Study Of Diabetes And Cancer Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Epidemiologic Study Of Diabetes And Cancer Risk', 'orgStudyIdInfo': {'id': 'AD-4833_403B'}, 'secondaryIdInfos': [{'id': 'EUPAS10335', 'type': 'REGISTRY', 'domain': 'EU PAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full KPNC Cohort', 'description': 'Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.', 'interventionNames': ['Other: No Intervention']}, {'label': 'Survey Responders', 'description': '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.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'armGroupLabels': ['Full KPNC Cohort', 'Survey Responders']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}