All Cancer IncidenceNCT02890667
Evaluation of Algorithms to Identify Incident Cancer Cases by Using French Health Administrative Databases
An observational study of All Cancer Incidence, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
"This study is a population based observational study conducted on the French administrative databases to estimate cancer incidence in 2012 by using the "ECHANTILLON GENERALISTE DES BENEFICIAIRES" (EGB, a 1/97th dynamic random sample of the SNIIRAM). Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- All Cancer Incidence
- What is being tested?
- Incident cancer
- How many people
- 447,694 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Beneficiaries present in the " ECHANTILLON GENERALISTE DES BENEFICIAIRES (EGB)" on January 1, 2012.
Who may be able to join
- Beneficiaries present in the EGB on January 1, 2012.
- Beneficiaries who are < 90 years old on January 1, 2012.
- Beneficiaries residing in metropolitan France.
- Beneficiaries affiliated with the general insurance scheme since January 1, 2011 or before.
Who cannot join
- No prevalent cancer before January 1, 2012; ( hospital discharge with a primary, related or associated diagnosis of cancer (C00-C97), or personal history of cancer (Z85); LTD status related to cancer; reimbursement for any cancer-specific drug; or external radiotherapy session).
About this study
Official title: A Population Based Observational Study Conducted on the French Administrative Databases to Estimate Cancer Incidence Using Outpatient Care and Hospital Discharge
"This study is a population based observational study conducted on the French administrative databases to estimate cancer incidence in 2012 by using the "ECHANTILLON GENERALISTE DES BENEFICIAIRES" (EGB, a 1/97th dynamic random sample of the SNIIRAM).
The EGB database contains anonymous and prospectively recorded data about all beneficiaries' medical reimbursements. Many algorithm definitions are defined to estimate the incident rate of cancer in 2012 from the EGB database. The incidence rates obtained by each algorithm definition are compared to national incidence rates by indirect age and sex standardization. National incidence rates are obtained from "FRANCE CANCER INCIDENCE ET MORTALITE" (FRANCIM): the French network of cancer registries."
Read the detailed description
"This study is a population based observational study conducted on the French administrative databases to estimate cancer incidence in 2012 by using the "ECHANTILLON GENERALISTE DES BENEFICIAIRES" (EGB, a 1/97th dynamic random sample of the SNIIRAM).
The EGB database contains anonymous and prospectively recorded data about all beneficiaries' medical reimbursements including age, gender, long-term chronic disease (LTD), date of death, all out-hospital health-spending reimbursements and all patients' hospitalizations. Many algorithm definitions are defined to estimate the incident rate of cancer in 2012 from the EGB database and are applied separately for men and women. These algorithms use information from either out-hospital care only (LTD status, anticancer specific drugs, outpatient radiotherapy sessions), or inpatient stays only (primary or related diagnosis of cancer, cancer-related procedures) or combine both information. The incidence rates obtained by each algorithm definition are compared to national incidence rates by indirect age and sex standardization. National incidence rates are obtained from FRANCE CANCER INCIDENCE ET MORTALITE (FRANCIM): the French network of cancer registries that has collected cancer cases since 1975 from 21 French registries (general or specific) covering 17 of the 95 French metropolitan departments. The most recent estimation of the FRANCIM network was published for 2012 and included all cancer locations (C00-C97) excluding non-melanoma skin cancer (C44).
Follow up All patients included are followed from January 1, 2012 until the occurrence of the first of death, cancer occurrence, moving out of the general insurance scheme or January 1, 2013.
To allow for comparison with data from cancer registries, only malignant neoplasms are considered: ICD-10 codes (C00-C97), excluding non-melanoma skin cancer (C44).
Statistical analysis
The number of incident cancer cases obtained with each algorithm is compared to the expected number of cancer cases calculated by using national estimation for the same age and sex stratum. The standardized incidence ratio (SIR) with 95% confidence intervals is calculated by indirect age and sex standardization. Age- and sex-specific incident rates are compared to the incident rates in 2012 estimated by FRANCIM.
The investigators also apply the most accurate algorithm separately for men and women to the 3 most common cancers in the corresponding gender by restricting the involved cancer codes, procedures and drugs to those related to the cancer of interest. The investigators also restrict our population to the most-studied age groups in cancer etiological studies (40 to 75 years). All the analyses are performed using SAS Enterprise Guide, version 4.3."
- Conditions
- All Cancer Incidence
- Being tested
- Incident cancer
- Keywords
- Cancer, incidence, health insurance data, algorithms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incident cancerOther
Also called observation of a cancer
The number of incident cancer cases
| Study group | Role | What they receive |
|---|---|---|
| Beneficiaries | Incident cancer for Beneficiaries present in the EGB on January 1, 2012. Receives: Other: Incident cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cancer incidence
Measured: 1 year
Secondary outcomes (4)
Prostate cancer incidence
Measured: 1 year
Breast cancer incidence
Measured: 1 year
Lung cancer incidence
Measured: 1 year
Colorectal cancer incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Cancer IncidenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 447,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aya AJROUCHE, Pharm.D, Principal investigator, CEPHEPI, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890667
- Sponsor's protocol ID
- PHRC-K 14-158
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population Based Observational Study Conducted on the French Administrative Databases to Estimate Cancer Incidence Using Outpatient Care and Hospital Discharge
- ClinicalTrials.gov ID
- NCT02890667
- Acronym / sponsor ID
- PHRC-K 14-158
- Conditions
- All Cancer Incidence
- Keywords
- Cancer, incidence, health insurance data, algorithms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447,694 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"This study is a population based observational study conducted on the French administrative databases to estimate cancer incidence in 2012 by using the "ECHANTILLON GENERALISTE DES BENEFICIAIRES" (EGB, a 1/97th dynamic random sample of the SNIIRAM).
The EGB database contains anonymous and prospectively recorded data about all beneficiaries' medical reimbursements. Many algorithm definitions are defined to estimate the incident rate of cancer in 2012 from the EGB database. The incidence rates obtained by each algorithm definition are compared to national incidence rates by indirect age and sex standardization. National incidence rates are obtained from "FRANCE CANCER INCIDENCE ET MORTALITE" (FRANCIM): the French network of cancer registries."
Detailed description
"This study is a population based observational study conducted on the French administrative databases to estimate cancer incidence in 2012 by using the "ECHANTILLON GENERALISTE DES BENEFICIAIRES" (EGB, a 1/97th dynamic random sample of the SNIIRAM).
The EGB database contains anonymous and prospectively recorded data about all beneficiaries' medical reimbursements including age, gender, long-term chronic disease (LTD), date of death, all out-hospital health-spending reimbursements and all patients' hospitalizations. Many algorithm definitions are defined to estimate the incident rate of cancer in 2012 from the EGB database and are applied separately for men and women. These algorithms use information from either out-hospital care only (LTD status, anticancer specific drugs, outpatient radiotherapy sessions), or inpatient stays only (primary or related diagnosis of cancer, cancer-related procedures) or combine both information. The incidence rates obtained by each algorithm definition are compared to national incidence rates by indirect age and sex standardization. National incidence rates are obtained from FRANCE CANCER INCIDENCE ET MORTALITE (FRANCIM): the French network of cancer registries that has collected cancer cases since 1975 from 21 French registries (general or specific) covering 17 of the 95 French metropolitan departments. The most recent estimation of the FRANCIM network was published for 2012 and included all cancer locations (C00-C97) excluding non-melanoma skin cancer (C44).
Follow up All patients included are followed from January 1, 2012 until the occurrence of the first of death, cancer occurrence, moving out of the general insurance scheme or January 1, 2013.
To allow for comparison with data from cancer registries, only malignant neoplasms are considered: ICD-10 codes (C00-C97), excluding non-melanoma skin cancer (C44).
Statistical analysis
The number of incident cancer cases obtained with each algorithm is compared to the expected number of cancer cases calculated by using national estimation for the same age and sex stratum. The standardized incidence ratio (SIR) with 95% confidence intervals is calculated by indirect age and sex standardization. Age- and sex-specific incident rates are compared to the incident rates in 2012 estimated by FRANCIM.
The investigators also apply the most accurate algorithm separately for men and women to the 3 most common cancers in the corresponding gender by restricting the involved cancer codes, procedures and drugs to those related to the cancer of interest. The investigators also restrict our population to the most-studied age groups in cancer etiological studies (40 to 75 years). All the analyses are performed using SAS Enterprise Guide, version 4.3."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beneficiaries | – | Other: Incident cancerIncident cancer for Beneficiaries present in the EGB on January 1, 2012. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Beneficiaries present in the " ECHANTILLON GENERALISTE DES BENEFICIAIRES (EGB)" on January 1, 2012.
Key inclusion criteria (4 listed)
- Beneficiaries present in the EGB on January 1, 2012.
- Beneficiaries who are < 90 years old on January 1, 2012.
- Beneficiaries residing in metropolitan France.
- Beneficiaries affiliated with the general insurance scheme since January 1, 2011 or before.
Key exclusion criteria (1 listed)
- No prevalent cancer before January 1, 2012; ( hospital discharge with a primary, related or associated diagnosis of cancer (C00-C97), or personal history of cancer (Z85); LTD status related to cancer; reimbursement for any cancer-specific drug; or external radiotherapy session).
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 |
|---|---|---|
| Incident cancerAlso: observation of a cancerThe number of incident cancer cases | Other | Beneficiaries |
Primary outcome
All Cancer incidence
Time frame: 1 year
4 secondary outcomes
Prostate cancer incidence
Time frame: 1 year
Breast cancer incidence
Time frame: 1 year
Lung cancer incidence
Time frame: 1 year
Colorectal cancer incidence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: Undecided
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.
Aya AJROUCHE, Pharm.D principal investigator
CEPHEPI, AP-HP
Questions about this trial
What is this clinical trial studying?
An observational study of All Cancer Incidence, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All Cancer incidence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.