Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02733601 |
| Other study ID # |
D133FR00109 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2016 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
AstraZeneca |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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
