Evaluation of Algorithms to Identify Incident Cancer Cases by Using French Health Administrative Databases

September 6, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

447694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Beneficiaries present in the " ECHANTILLON GENERALISTE DES BENEFICIAIRES (EGB)" on January 1, 2012.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Beneficiaries
Incident cancer for Beneficiaries present in the EGB on January 1, 2012.
Other: Incident cancer
The number of incident cancer cases
Other Names:
  • observation of a cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All Cancer incidence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer incidence
Time Frame: 1 year
1 year
Breast cancer incidence
Time Frame: 1 year
1 year
Lung cancer incidence
Time Frame: 1 year
1 year
Colorectal cancer incidence
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Aya AJROUCHE, Pharm.D, CEPHEPI, AP-HP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHRC-K 14-158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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