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

Overview

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.

Full Title of Study: “LuCaReAl: Lung Cancer Registry in Algeria.”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2021

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

Interventions

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

Arms, Groups and Cohorts

  • lungcancer patients
    • Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • incidence of newly diagnosed lung cancer
    • Time Frame: 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
    • 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.
    • 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kamel Bouzid, Principal Investigator, CPMC
    • Habib Douagui, respiratory Diseases, Principal Investigator, Beni messous

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