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

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.

Study Overview

• Status: Completed
• Conditions: Oncology & Epidemiology & Lung Cancer
• Intervention / Treatment: Other: NIS observational stud

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 Type: Observational
• Enrollment (Actual): 897

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria, 16000
    • Research Site
  • Constantine, Algeria, 25000
    • Research Site
  • Oran, Algeria, 31000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lungcancer patients; Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist	Other: NIS observational stud; NIS observational study : Epidemiologic registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
survival		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 )	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	baseline, 3, 6 and 12 months follow-up.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kamel Bouzid, CPMC; Principal Investigator: Habib Douagui, respiratory Diseases, Béni Messous

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2016
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer epidemiology algeria registry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: D133FR00108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.