- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694171
Access to Care and Prognosis in Elderly With Cancer (INCAPAC Study)
Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department
Study Overview
Status
Conditions
Detailed Description
The French department of Gironde (1.5 million inhabitants) is covered by cancer registries. In addition, three cohorts were initiated in Gironde on cerebral and functional aging that enrolled subjects aged 65 years and over: the PAQUID study (1988), the 3-City study (1999), and the AMI study (2007). In these cohorts, a large amount of individual data on the participants has been collected longitudinally at different follow-up visits, conducted every two or three years.
Using cancer registries, older subjects with cancer were identified in the cohort studies. Subjects were included if they presented the following: i) aged 65 years and over from one of the three cohorts, ii) alive on January 1st 2005 (common start date for tumor recording) and resident in Gironde, and iii) with a validated cancer diagnosis recorded in one of the cancer registries from January 1st 2005 to December 31st 2014. All tumors for which data is annually sent by cancer registries to the International Agency for Research of Cancer were included: invasive malignant tumors and benign tumors of the central nervous system. As the incidence of skin tumors in older cancer patients is high, they were also included. For patients with multiple tumors, only one was considered: either the first one diagnosed if there were several tumors with a minimum of a 6 months interval between their diagnosis, or the one with the worse prognosis if there were several tumors diagnosed within 6 months.
In order to not consider information concerning patients' characteristics that was too old, subjects with a delay between the last completed cohort follow-up visit before the cancer diagnosis and the diagnosis of cancer equal or superior to 6 years were excluded.
Variables were extracted from cohorts and registries at different times: cohort inclusion, pre-diagnosis visit, cancer diagnosis or registries follow-up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- Institut Bergonie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 65 years
- Alive on January 1st 2005 ( PAQUID or 3-City cohorts) or included in the AMI cohort study
- Cancer diagnosis recorded in one of the cancer registries in Gironde, French department
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer stage at diagnosis
Time Frame: 2005 to 2014
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Advanced stage at diagnosis measured from cancer registries data
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2005 to 2014
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Cancer treatment
Time Frame: Through study completion
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Receipt of cancer treatment (all treatment considered) from cancer registries data
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Through study completion
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Functional decline
Time Frame: An average of 2 years
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Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Instrumental Activities of Daily Living (IADL) scale
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An average of 2 years
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Functional decline
Time Frame: An average of 2 years
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Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Activities of Daily Living (ADL) scale
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An average of 2 years
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Survival
Time Frame: July, 31st 2017
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Time from cancer diagnosis to death or last follow-up, whichever came first
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July, 31st 2017
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Collaborators and Investigators
Publications and helpful links
General Publications
- Galvin A, Helmer C, Coureau G, Amadeo B, Joly P, Sabathe C, Monnereau A, Baldi I, Rainfray M, Soubeyran P, Delva F, Mathoulin-Pelissier S. Determinants of cancer treatment and mortality in older cancer patients using a multi-state model: Results from a population-based study (the INCAPAC study). Cancer Epidemiol. 2018 Aug;55:39-44. doi: 10.1016/j.canep.2018.04.013. Epub 2018 May 25.
- Galvin A, Delva F, Helmer C, Rainfray M, Bellera C, Rondeau V, Soubeyran P, Coureau G, Mathoulin-Pelissier S. Sociodemographic, socioeconomic, and clinical determinants of survival in patients with cancer: A systematic review of the literature focused on the elderly. J Geriatr Oncol. 2018 Jan;9(1):6-14. doi: 10.1016/j.jgo.2017.07.007. Epub 2017 Oct 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IB2013 INCAPAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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