An observational study in Oncology, Epidemiology and Breast Cancer, sponsored by AstraZeneca. Completed at 3 sites in Algeria. Open to female participants. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by AstraZeneca · Observational
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.
The study consists of:
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 1,500 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Compared within Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be eligible to participate to the study if they fulfil all of the following criteria:
Exclusion Criteria:
Patients will not be eligible to participate if any of the following criteria are present:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: NIS (Non Interventional Study) observational study
NIS observational study : Epidemiologic registry
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
Time frame: 60 months
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.
Time frame: 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).
Time frame: 60 months
Incidence by stage
Number of new diagnosed patients by stage (TNM classification sub population).
Time frame: 60 months
Plan to share: 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from May 2016 to primary completion in Mar 2022, 70 months.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 70 months is above that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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