An observational study in Lung Neoplasms, Carcinoma, Non-Small-Cell Lung and Carcinoma, Small Cell, sponsored by Société Algérienne de Formation et de Recherche en Oncologie. Recruiting at 21 sites in Algeria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Société Algérienne de Formation et de Recherche en Oncologie · Observational
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.
Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide, and its incidence continues to rise in Algeria. Despite this increasing burden, real-world data regarding the epidemiology, clinical management, and treatment outcomes of lung cancer remain limited at the national level. The SAFRO 2202 ALG-Lung Cancer Registry was established to fill this gap by systematically collecting prospective, real-life data from a large sample of patients managed within Algeria's public healthcare system.
This study is a prospective, multicenter, non-interventional observational registry conducted across 21 hospital centers specialized in oncology and pulmonology. It includes adult patients (aged ≥18 years) with a confirmed diagnosis of lung cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and carcinoid tumors. The study includes all patients diagnosed at the time of inclusion or within the 12 months preceding inclusion, provided they meet the eligibility criteria. All patients must be fully managed within the public healthcare system, including diagnosis, treatment, and follow-up.
Data will be collected as part of routine medical care, with no study-specific visits required, and will be entered into a secure electronic case report form (eCRF). Collected variables include demographic information, medical history, risk factors (especially smoking), tumor histology and molecular characteristics (e.g., EGFR, ALK, PD-L1, KRAS, ROS1, RET), ECOG performance status, and treatment modalities across different therapeutic lines.
The registry will also assess real-world treatment patterns and clinical outcomes, including objective response rate (based on RECIST 1.1), progression-free survival (PFS), time to treatment discontinuation (TTD), and overall survival (OS). Adverse events and treatment-related toxicities will be documented and classified according to international standards (CTCAE). A minimum of 1,500 patients per year is expected, with at least 12 months of follow-up per patient.
This project aims to create a reliable national database to support health policy, optimize therapeutic strategies, and guide clinical research. By accounting for variations in clinical practices and patient profiles across the country, SAFRO 2202 is expected to generate robust evidence to improve lung cancer care in Algeria.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 3,750 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →This is the only study on the registry with Société Algérienne de Formation et de Recherche en Oncologie as lead sponsor.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (≥18 years) diagnosed with lung cancer (NSCLC, SCLC, or carcinoid tumors) at the time of inclusion or within the previous 12 months, fully managed in oncology or pulmonology departments at one of the 21 participating public or university hospitals across Algeria. Data are collected prospectively during routine clinical care.
Other: Observational Data Collection
Collection of clinical, pathological, molecular, and treatment-related data during routine care, with no additional procedures or interventions required by the study.
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)
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)
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)
First-line treatment modalities
Type of initial treatment received (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy).
Time frame: At baseline (initiation of treatment)
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 months
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 months
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 months
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 months
Overall Survival (OS)
Time from date of diagnosis to death from any cause, based on real-world clinical follow-up.
Time frame: Minimum 12-month follow-up after diagnosis
Plan to share: No — The IPD will not be shared with external researchers. The data will be used exclusively by the study team for the purpose of scientific analysis and publication. No external access to individual-level data is planned.
No publications or documents are linked to this record.
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Carcinoma, Non-Small-Cell Lung →