CancerNCT03694171
Access to Care and Prognosis in Elderly With Cancer (INCAPAC Study)
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Any cancer treatment
- Type of treatment
- Injection or infusion
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects aged 65 and over with a diagnosis of cancer recorded in one of the cancer registries in Gironde, French department.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Any cancer treatment
- Keywords
- Elderly, Cancer, Cohort study, Cancer registry, Access to care, Cancer stage, Cancer treatment, Prognosis, Functional decline, Survival
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any cancer treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Any cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Being Receiving Treatment Administration After Diagnosis
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.
Measured: At diagnosis
The Probability of Being Dead at One Year
The probability of being dead with or without receiving cancer treatment at least once (death)
Measured: one year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startNov 2013
- Primary completionNov 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Simone Mathoulin-Pelissier, MD-PhD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694171
- Sponsor's protocol ID
- IB2013 INCAPAC
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2018
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29763754Galvin 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.
PubMed 29030150
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department
- ClinicalTrials.gov ID
- NCT03694171
- Acronym / sponsor ID
- IB2013 INCAPAC
- Conditions
- Cancer
- Keywords
- Elderly, Cancer, Cohort study, Cancer registry, Access to care, Cancer stage, Cancer treatment, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Bordeaux
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients with cancer | – | Other: Any cancer treatmentSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects aged 65 and over with a diagnosis of cancer recorded in one of the cancer registries in Gironde, French department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any cancer treatment | Other | Older patients with cancer |
Primary outcome
Proportion of Patients Being Receiving Treatment Administration After Diagnosis
Time frame: At diagnosis
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.
The Probability of Being Dead at One Year
Time frame: one year after diagnosis
The probability of being dead with or without receiving cancer treatment at least once (death)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29763754Galvin 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.
- Results publication: PubMed 29030150Galvin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Mathoulin-Pelissier, MD-PhD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Being Receiving Treatment Administration After Diagnosis (time frame: At diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694171, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.