OncologyBreCaReAlNCT02733601
Epidemiology of Breast Cancer in Women Based on Diagnosis Data From Oncologists and Breast Surgeons in Algeria
An observational study of Oncology and Epidemiology, run by AstraZeneca at 3 sites in Algeria.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Oncology, Epidemiology, Breast Cancer
- What is being tested?
- NIS (Non Interventional Study) observational study
- How many people
- 1,500 participants
- Where
- 3 sitesAlgeria
- Study dates
- 29 May 2016to 31 Mar 2022
- How long will I take part?
- 5 Years
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Algeria3 sites
Research Site
East of Algeria, East of Algeria, 25 000
Research Site
Middle of Algeria, Middle of Algeria, 16 000
Research Site
Ouest of Algeria/ Oran Region, Ouest of Algeria/ Oran Region, 31 000
About this study
Official title: BreCaReAl: Breast Cancers Registry in Algeria
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.
Read the 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
- Conditions
- Oncology, Epidemiology, Breast Cancer
- Being tested
- NIS (Non Interventional Study) observational study
- Keywords
- breast cancer epidemiology algeria registry
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIS (Non Interventional Study) observational studyOther
NIS observational study : Epidemiologic registry
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | 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 Receives: Other: NIS (Non Interventional Study) observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival status at 05 years (percentage of patients still alive at 05 years)
Survival status at 60 months based on the percentage of patients still alive at 05 years
Measured: 60 months
Secondary outcomes (3)
incidence all cases
Number of new diagnosed cases of breast cancer, all stages combined, by oncologists and breast surgeons, in pre- and post-menopausal women, related to the general female population in Algeria over 06 months of recruitment period.
Measured: 06 months
Incidence by age
Number of new cases diagnosed with breast cancer by age (18 - 20, 20-30, 30 - 40, 40 - 50, 50-60, 60 - 70 and > 70 years old).
Measured: 60 months
Incidence by stage
Number of new diagnosed patients by stage (TNM classification sub population).
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start29 May 2016
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Bendib, Oncologist, Principal investigator, CPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733601
- Sponsor's protocol ID
- D133FR00109
- Acronym
- BreCaReAl
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2016
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BreCaReAl: Breast Cancers Registry in Algeria
- ClinicalTrials.gov ID
- NCT02733601
- Acronym / sponsor ID
- BreCaReAl / D133FR00109
- Conditions
- Oncology, Epidemiology, Breast Cancer
- Keywords
- breast cancer epidemiology algeria registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 May 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 11 Apr 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Other: NIS (Non Interventional Study) observational studyNewly 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| NIS (Non Interventional Study) observational studyNIS observational study : Epidemiologic registry | Other | Breast Cancer Patients |
Primary outcome
Survival status at 05 years (percentage of patients still alive at 05 years)
Time frame: 60 months
Survival status at 60 months based on the percentage of patients still alive at 05 years
3 secondary outcomes
incidence all cases
Time frame: 06 months
Incidence by age
Time frame: 60 months
Incidence by stage
Time frame: 60 months
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 3 Apr 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Ahmed Bendib, Oncologist principal investigator
CPMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Epidemiology, run by AstraZeneca at 3 sites in Algeria.
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 5 inclusion and 4 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Survival status at 05 years (percentage of patients still alive at 05 years) (time frame: 60 months). 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 3 Apr 2023.