Incident cancer for Beneficiaries present in the EGB on January 1, 2012.

Incident cancer

Aya AJROUCHE, Pharm.D

"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."

"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."

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

A Population Based Observational Study Conducted on the French Administrative Databases to Estimate Cancer Incidence Using Outpatient Care and Hospital Discharge

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Syndrome

Apnea

Sleep Apnea Syndromes

Death

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.

Questionnaire

Marie JOYEUX-FAURE, PharmD

Jean-Louis PEPIN, MD

Marie Joyeux-Faure, PharmD, PhD

Jean-Louis Pépin, MD, PhD

Renaud Tamisier, MD, PhD

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).

The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

Prevalence of cardiovascular events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Prevalence of metabolic events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Prevalence of incident cancers during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire..

Prevalence of deaths during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the cardiovascular events occurrence.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the metabolic events occurrence.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the incident cancers occurrence.

University Hospital, Grenoble

Patients included in the ESADA European database and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Marie Joyeux-Faure, PharmD, PhDm

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The European database ESADA prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. A partnership agreement exists between University Hospital Grenoble (CHUGA) and ESADA for the reuse of CHUGA data. The data collected at CHUGA as part of the ESADA-Follow-up and outcomes questionnaire are also collected in the other European centers and will be centralized at the level of the coordinating center.

ESADA currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome. One of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating European centers to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the cardiovascular events occurrence.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the metabolic events occurrence.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the incident cancers occurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Algorithms to Identify Incident Cancer Cases by Using French Health Administrative Databases	NCT02890667	All Cancer Inci...	Incident cancer	- 90 Years	Assistance Publique - Hôpitaux de Paris
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)	NCT04800341	Sleep Apnea	Questionnaire	18 Years - 80 Years	University Hospital, Grenoble
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)	NCT04800341	Sleep Apnea	Questionnaire	18 Years - 80 Years	University Hospital, Grenoble
Evaluation of Algorithms to Identify Incident Cancer Cases by Using French Health Administrative Databases	NCT02890667	All Cancer Inci...	Incident cancer	- 90 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for incident cancer