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

Completed

• Conditions: Oncology & Epidemiology & Lung Cancer
• Interventions: Other: NIS observational stud

• Registration Number: NCT02725892
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Study Start: 2016-07-19
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lungcancer patients	NIS observational stud	Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist

Primary Outcome Measures

Name	Time	Method
incidence of lung cancer	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

Secondary Outcome Measures

Name	Time	Method
incidence of newly diagnosed lung cancer	12 month period	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).
survival	at 12, 24, 36, 48 and 60 months of follow-up.
quality of life -EORTC QLQ-C30	baseline, 3, 6 and 12 months follow-up.	To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ-C30 )
Quality Of Life-EORTC QLQ- LC13	baseline, 3, 6 and 12 months follow-up.	To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ- LC13

Trial Locations

Locations (1)

Research Site; 🇩🇿 Oran, Algeria