National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria

Oncology & Epidemiology & Lung Cancer Clinical Trial

— LuCaReAl  

Official title:

LuCaReAl: Lung Cancer Registry in Algeria.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725892
• Other study ID #: D133FR00108
• Status: Completed
• Start date: July 19, 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 897
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Oncology & Epidemiology & Lung Cancer

Intervention

Other:
• NIS observational stud
NIS observational study : Epidemiologic registry

Locations

Country	Name	City	State
Algeria	Research Site	Algiers
Algeria	Research Site	Constantine
Algeria	Research Site	Oran

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months of recruitment period
Secondary	incidence of newly diagnosed lung cancer	1) 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).	12 month period
Secondary	survival		at 12, 24, 36, 48 and 60 months of follow-up.
Secondary	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 )	baseline, 3, 6 and 12 months follow-up.
Secondary	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	baseline, 3, 6 and 12 months follow-up.

External Links

•   Redacted CSR Synopsis