Clinical trial NCT02725892: National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria
Official title: LuCaReAl: Lung Cancer Registry in Algeria.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology & Epidemiology & Lung Cancer
Keywords: lung cancer epidemiology algeria registry
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 897
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who did not provide the informed consent form
* Patients with a mental or psychological disorder according to their treating clinicians

Primary outcomes:
measure: incidence of lung cancer
timeFrame: 12 months of recruitment period
Secondary outcomes:
measure: incidence of newly diagnosed lung cancer
timeFrame: 12 month period
measure: survival
timeFrame: at 12, 24, 36, 48 and 60 months of follow-up.
measure: quality of life -EORTC QLQ-C30
timeFrame: baseline, 3, 6 and 12 months follow-up.
measure: Quality Of Life-EORTC QLQ- LC13
timeFrame: baseline, 3, 6 and 12 months follow-up.
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Research Site
city: Constantine
country: Algeria
facility: Research Site
city: Oran
country: Algeria
facility: Research Site
Study officials:
affiliation: CPMC
name: Kamel Bouzid
role: PRINCIPAL_INVESTIGATOR
affiliation: Beni messous
name: Habib Douagui, respiratory Diseases
role: PRINCIPAL_INVESTIGATOR
References: