Oncology & Epidemiology & Lung CancerLuCaReAlNCT02725892
National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria
An observational study of Oncology & Epidemiology & Lung Cancer, run by AstraZeneca at 3 sites in Algeria.
Trial summary
National, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology & Epidemiology & Lung Cancer
- What is being tested?
- NIS observational stud
- How many people
- 897 participants
- Where
- 3 sitesAlgeria
- Study dates
- 19 Jul 2016to 28 Feb 2021
- How long will I take part?
- 72 Months
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: each sanitary region defined by the Ministry of health, the investigational centres will propose to all patients whom met illegibility criteria to participate to the study. Whenever possible, comprehensive lists of hospitals will be used as a data source in the site selection process. Lists will be obtained either from national authorities, 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 for the present study if they can provide a representative sample. The formal sample size will be calculated among the representatives hospitals sites overall the country.
Who may be able to join
- Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist
- Aged at least18 years at diagnosis
- Patients who provide their informed consent form
Who cannot join
- Patients who did not provide the informed consent form
- Patients with a mental or psychological disorder according to their treating clinicians
Trial locations and contacts
3 sites in 1 country.
Algeria3 sites
Research Site
Algiers, 16000
Research Site
Constantine, 25000
Research Site
Oran, 31000
About this study
Official title: LuCaReAl: Lung Cancer Registry in Algeria.
National, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria.
The study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.
Read the detailed description
The study consists of:
- All patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study.
- The patients who do not consent will only be reported as new case of lung cancer for the incidence study.
The patients who consent to participate to the study will perform four in-hospital visits (Inclusion visit, visit at 3, 6 and 12 months). In addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the CRO or during a routine visit to the investigator, to check the patient's survival status.
THE STUDY DURATION 72 MONTHS
- Conditions
- Oncology & Epidemiology & Lung Cancer
- Being tested
- NIS observational stud
- Keywords
- lung cancer epidemiology algeria registry
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIS observational studOther
NIS observational study : Epidemiologic registry
| Study group | Role | What they receive |
|---|---|---|
| lungcancer patients | Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist Receives: Other: NIS observational stud |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of lung cancer
incidence of lung cancer, all types, stages and ages combined, in men and women newly diagnosed with lung cancer in Algeria over 12 months of recruitment period
Measured: 12 months of recruitment period
Secondary outcomes (4)
incidence of newly diagnosed lung cancer
- To characterise the incidence of newly diagnosed lung cancer in Algeria in a 12 month period according to patient and disease characteristics (Wilaya, sex, age, lung cancer type, stage disease and smoking status).
Measured: 12 month period
survival
Measured: at 12, 24, 36, 48 and 60 months of follow-up.
quality of life -EORTC QLQ-C30
To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ-C30 )
Measured: baseline, 3, 6 and 12 months follow-up.
Quality Of Life-EORTC QLQ- LC13
To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ- LC13
Measured: baseline, 3, 6 and 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start19 Jul 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology & Epidemiology & Lung CancerStudies 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
- 897 participants (actual)
- Target duration
- 72 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamel Bouzid, Principal investigator, CPMCHabib Douagui, respiratory Diseases, Principal investigator, Beni messous
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725892
- Sponsor's protocol ID
- D133FR00108
- Acronym
- LuCaReAl
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2016
- Last updated
- 16 Mar 2022
- Results posted
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LuCaReAl: Lung Cancer Registry in Algeria.
- ClinicalTrials.gov ID
- NCT02725892
- Acronym / sponsor ID
- LuCaReAl / D133FR00108
- Conditions
- Oncology & Epidemiology & Lung Cancer
- Keywords
- lung cancer epidemiology algeria registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 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, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria.
The study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.
Detailed description
The study consists of:
- All patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study.
- The patients who do not consent will only be reported as new case of lung cancer for the incidence study.
The patients who consent to participate to the study will perform four in-hospital visits (Inclusion visit, visit at 3, 6 and 12 months). In addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the CRO or during a routine visit to the investigator, to check the patient's survival status.
THE STUDY DURATION 72 MONTHS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 72 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lungcancer patients | – | Other: NIS observational studMen or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- each sanitary region defined by the Ministry of health, the investigational centres will propose to all patients whom met illegibility criteria to participate to the study. Whenever possible, comprehensive lists of hospitals will be used as a data source in the site selection process. Lists will be obtained either from national authorities, 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 for the present study if they can provide a representative sample. The formal sample size will be calculated among the representatives hospitals sites overall the country.
Key inclusion criteria (3 listed)
- Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist
Key exclusion criteria (2 listed)
- Patients who did not provide the informed consent form
- Patients with a mental or psychological disorder according to their treating clinicians
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 observational studNIS observational study : Epidemiologic registry | Other | lungcancer patients |
Primary outcome
incidence of lung cancer
Time frame: 12 months of recruitment period
incidence of lung cancer, all types, stages and ages combined, in men and women newly diagnosed with lung cancer in Algeria over 12 months of recruitment period
4 secondary outcomes
incidence of newly diagnosed lung cancer
Time frame: 12 month period
survival
Time frame: at 12, 24, 36, 48 and 60 months of follow-up.
quality of life -EORTC QLQ-C30
Time frame: baseline, 3, 6 and 12 months follow-up.
Quality Of Life-EORTC QLQ- LC13
Time frame: baseline, 3, 6 and 12 months follow-up.
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 16 Mar 2022.
- Redacted CSR SynopsisLink 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.
Kamel Bouzid principal investigator
CPMC
Habib Douagui, respiratory Diseases principal investigator
Beni messous
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 & Epidemiology & Lung Cancer, 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 3 inclusion and 2 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 16 Mar 2022. 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?
incidence of lung cancer (time frame: 12 months of recruitment period). 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 16 Mar 2022.