Clinical trial NCT02733601: Epidemiology of Breast Cancer in Women Based on Diagnosis Data From Oncologists and Breast Surgeons in Algeria
Official title: BreCaReAl: Breast Cancers Registry in Algeria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Epidemiology
Breast Cancer
Keywords: breast cancer epidemiology algeria registry
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include representative centres of breast cancer managing departments in each sanitary region defined by the Ministry of health, the investigational centres will propose to all patients whom met eligibility criteria to participate to the study. 1500 patients are expected to be enrolled in the study (incidence study).

Brief summary: National, prospective, multicentre, non-interventional epidemiological study, conducted among oncologists and breast surgeons in community and university hospitals, from the public sector in Algeria.

The study will collect information on the characteristics, and breast carcinomas patterns of patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study will be conducted over a representative, but not exhaustive sample of Algerian female patients.

Detailed description: The study consists of:

* Four in-hospital visits (inclusion visit, visit at 3 months, visit at 6 months, visit at 12 months). All patients presenting to their oncologists/breast surgeons during a routine visit and meeting eligibility criteria will be sequentially asked to participate to the study
* In addition to the 4 visits, a phone contact with the patients will be done by the investigator or the CRO (Clinical Research Organization, independent person) or during a routine visit to the investigator, to check the patients' survival every 6 months during 5 years (8 contacts).

Duration of patient recruitment: 6 months from the date of first patient's inclusion.

Duration of patient follow-up: 60 months 3.2 Data Source A comprehensive list of all Algeria hospitals will be used as a data source in the site selection process. The list will be obtained either from the health authority, local scientific societies or professional associations, depending on the local availability of this type of information. All efforts will be made to approach and select sites/physicians.

The oncologist/breast surgeons (investigator) or one of his/her authorised representative in each participating site will complete a CRF (Case Report Form). All data to be collected will be based on the patient's medical file.

The patient will also complete an auto-questionnaire about quality of life at inclusion, 6 and 12 months follow-up.

The CRF will collect all data required for the study and will be transmitted to the project team for analysis following each eligible patient's visit to the investigator.

Data collection should be precise and reliable. The study monitor will verify the authenticity of the data, by matching the CRF with the source documents at the site, and in compliance with the guidelines for good pharmacoepidemiology practices and the recommendations of the Association of French-speaking Epidemiologists (ADELF).

In total, 10 to 15% of the eCRFs (electronic Case Report Form) by site will be verified.

Following the data verification, lists of non-conformity will be generated and transmitted to the study investigators.

The investigator should provide the Sponsor, when requested, all necessary and important data for control. The access to the complete patient's medical file, should be authorised by the investigator, providing that the patient's confidentiality is preserved.

Patients who do not give their written informed consent will only be listed, their data will not be collected on the patient form by the Sponsor.

In case of any particular problem, an audit request can be made.

This study will include representative centres of breast cancer managing departments in each sanitary region defined by the Ministry of health, the investigational centres will propose to all patients whom met eligibility criteria to participate to the study. 1500 patients are expected to be enrolled in the study (incidence study).

Study duration: 66 months

Eligibility criteria: Inclusion Criteria:

Patients will be eligible to participate to the study if they fulfil all of the following criteria:

* Female patients
* Aged 18 years and over
* Newly diagnosed with breast cancer all stages confirmed during the study period by an anatomopathologist, defined as a first diagnosis of breast cancer based on anatomopathological results from at least a microbiopsy
* Provision of subject informed consent.

Exclusion Criteria:

Patients will not be eligible to participate if any of the following criteria are present:

* Informed consent not obtained.
* Patients with a mental or psychological disorder according to their treating clinicians
* Patients participating in an interventional study or already included in the study. A patient could be consulted and treated in two different centres, thus a codification system will be generated to avoid duplicate participation

Primary outcomes:
measure: Survival status at 05 years (percentage of patients still alive at 05 years)
timeFrame: 60 months
Secondary outcomes:
measure: incidence all cases
timeFrame: 06 months
measure: Incidence by age
timeFrame: 60 months
measure: Incidence by stage
timeFrame: 60 months
Other outcomes:
Locations:
city: East Of Algeria
country: Algeria
facility: Research Site
city: Middle Of Algeria
country: Algeria
facility: Research Site
city: Ouest Of Algeria/ Oran Region
country: Algeria
facility: Research Site
Study officials:
affiliation: CPMC
name: Ahmed Bendib, Oncologist
role: PRINCIPAL_INVESTIGATOR
References: