ALG-LungCancerRegistry (SAFRO2202)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Algérienne de Formation et de Recherche en Oncologie
About this trial
SAFRO 2202 ALG-Lung Cancer Registry is a prospective, multicenter, non-interventional observational study conducted across 21 public and university hospitals in Algeria. The objective is to characterize the epidemiological, clinical, pathological, molecular, and therapeutic features of patients diagnosed with lung cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and carcinoid tumors.
Eligible participants are adults aged 18 years or older, diagnosed at the time of inclusion or within the previous 12 months, and fully managed in oncology or pulmonology departments. Data are collected during routine clinical care and recorded in a secure electronic case report form (eCRF). No protocol-mandated interventions or study-specific visits are required.
The study plans to enroll approximately 1,500 patients per year over a 30-month period. Primary outcomes include demographic and clinical profiles, tumor histology, molecular markers, staging at diagnosis, and treatment strategies (surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy). Secondary outcomes include treatment-related toxicities, objective response rate (ORR), progression-free survival (PFS), time to treatment discontinuation (TTD), and overall survival (OS).
The findings from this registry will provide real-world evidence to support national health planning, improve lung cancer management, and guide future clinical and public health initiatives in Algeria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Histologically confirmed diagnosis of lung cancer (NSCLC, SCLC, or carcinoid tumor)
Diagnosed at the time of inclusion or within the 12 previous months
Fully managed (diagnosis, treatment, and follow-up) in an oncology or pulmonology department of one of the 21 participating public/university hospitals
Disqualifiers
Prior enrollment in this study
Participation in an interventional clinical trial
Trial population
Adult patients diagnosed with lung cancer (NSCLC, SCLC, or carcinoid tumors), recruited across 21 public or university hospitals in Algeria. Patients must have been diagnosed within 12 months prior to inclusion and be managed entirely within the public healthcare system.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Data Collection
Other interventionCollection of clinical, pathological, molecular, and treatment-related data during routine care, with no additional procedures or interventions required by the study.
Treatment groups
3,750 Participants
are divided into 1 treatment groupGroup A: Lung Cancer Patients Cohort1 intervention
Trial outcomes
Primary outcomes
1
Sociodemographic and clinical characteristics of lung cancer patients in Algeria
Patient age, sex, smoking history, comorbidities (e.g., COPD, diabetes, cardiovascular disease) and ECOG performance status, collected via eCRFs at inclusion in 21 oncology and pulmonology centers.
Time frame
At baseline (inclusion)2
Histological type and stage of lung cancer at diagnosis
Histological subtypes (NSCLC, SCLC, carcinoid tumors) and TNM stage of disease at diagnosis.
Time frame
At baseline (diagnosis/inclusion)3
Molecular profile of tumors
Frequency of molecular alterations (EGFR, ALK, KRAS, PD-L1, ROS1, RET, HER2, NTRK1, BRAF, MET, PIK3CA, MEK1) identified in tumor samples at diagnosis.
Time frame
At baseline (inclusion)4
First-line treatment modalities
Type of initial treatment received (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy).
Time frame
At baseline (initiation of treatment)Secondary outcomes
1
Treatment-related toxicity according to CTCAE
Incidence, type, classification, severity, and impact of adverse events related to lung cancer treatments, assessed with CTCAE criteria.
Time frame
From treatment initiation up to 12 months2
Objective Response Rate (ORR)
Proportion of patients achieving complete or partial tumor response, assessed according to RECIST 1.1 criteria, based on real-world clinical and radiological data.
Time frame
From treatment initiation up to 12 months3
Progression-Free Survival (PFS)
Time from treatment initiation to first documented disease progression or death from any cause, whichever occurs first.
Time frame
From treatment initiation up to 12 months4
Time to Treatment Discontinuation (TTD)
Time from treatment initiation to discontinuation of therapy for any reason, including toxicity, disease progression, or patient/physician decision.
Time frame
From treatment initiation up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Société Algérienne de Formation et de Recherche en Oncologie
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov