- 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
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
- 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Older patients with cancer
Subjects i) aged 65 years and over from the PAQUID, the 3City or the AMI study; ii) alive on January 1st 2005 (common start date of tumor recording); iii) resident in Gironde; and iv) with a validated cancer diagnosis recorded in one of the cancer registries from January 1st 2005 to December 31st 2014.
We included all invasive malignant tumors (including skin tumors) and benign tumors of the central nervous system.
For patients with multiple tumors, only one was considered: i) the first one diagnosed if there were several tumors with a minimum of a 6 months interval between their diagnosis, ii) the one with the worse prognosis if there were several tumors diagnosed within less than 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Patients Being Receiving Treatment Administration After Diagnosis
Time Frame: At diagnosis
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Treatment administration was defined as any cancer treatment (versus no treatment) including curative, palliative and symptomatic treatments. This information was registered by registries and qualified as unknown when no information was available about treatment receipt. |
At diagnosis
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The Probability of Being Dead at One Year
Time Frame: one year after diagnosis
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The probability of being dead with or without receiving cancer treatment at least once (death)
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one year after diagnosis
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Simone Mathoulin-Pelissier, MD-PhD, Institut Bergonie
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
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