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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03694171
Other study ID # IB2013 INCAPAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date November 2017

Study information

Verified date May 2019
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The growing incidence of cancer associated to an aging population represents an epidemiologic reality that requires questioning access to care and prognosis in elderly with cancer, for which disparities have been highlighted. However, generally speaking, studies are limited in that they overlook geriatric-specific factors. The aim of this work was to study sociodemographic, socioeconomic and clinical determinants of access to care (cancer stage, cancer treatment) and prognosis (functional decline, survival) in elderly cancer patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date November 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Institut Bergonié Bordeaux

Sponsors (3)

Lead Sponsor Collaborator
Institut Bergonié Institut National de la Santé Et de la Recherche Médicale, France, University of Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View Citation

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 po — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cancer stage at diagnosis Advanced stage at diagnosis measured from cancer registries data 2005 to 2014
Primary Cancer treatment Receipt of cancer treatment (all treatment considered) from cancer registries data Through study completion
Primary Functional decline Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Instrumental Activities of Daily Living (IADL) scale An average of 2 years
Primary Functional decline Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Activities of Daily Living (ADL) scale An average of 2 years
Primary Survival Time from cancer diagnosis to death or last follow-up, whichever came first July, 31st 2017
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