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NCT Number: NCT07161882

ALG-LungCancerRegistry (SAFRO2202)

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.

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Key information

Conditions

Lung Neoplasms Adenocarcinoma Bronchial Neoplasms Carcinoid Tumor Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Mohamed Lamine Debaghine - Bab-el-Oued, Algiers, Algiers Province, Algeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Signed informed consent obtained

Exclusion criteria

  • Prior enrollment in this study
  • Participation in an interventional clinical trial

Treatment and study plan

Observational Data Collection

Other

Collection of clinical, pathological, molecular, and treatment-related data during routine care, with no additional procedures or interventions required by the study.

Primary outcomes

  1. Sociodemographic and clinical characteristics of lung cancer patients in Algeria

    Time frame: At baseline (inclusion)

    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.

  2. Histological type and stage of lung cancer at diagnosis

    Time frame: At baseline (diagnosis/inclusion)

    Histological subtypes (NSCLC, SCLC, carcinoid tumors) and TNM stage of disease at diagnosis.

  3. Molecular profile of tumors

    Time frame: At baseline (inclusion)

    Frequency of molecular alterations (EGFR, ALK, KRAS, PD-L1, ROS1, RET, HER2, NTRK1, BRAF, MET, PIK3CA, MEK1) identified in tumor samples at diagnosis.

  4. First-line treatment modalities

    Time frame: At baseline (initiation of treatment)

    Type of initial treatment received (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy).

Secondary outcomes

  1. Treatment-related toxicity according to CTCAE

    Time frame: From treatment initiation up to 12 months

    Incidence, type, classification, severity, and impact of adverse events related to lung cancer treatments, assessed with CTCAE criteria.

  2. Objective Response Rate (ORR)

    Time frame: From treatment initiation up to 12 months

    Proportion of patients achieving complete or partial tumor response, assessed according to RECIST 1.1 criteria, based on real-world clinical and radiological data.

  3. Progression-Free Survival (PFS)

    Time frame: From treatment initiation up to 12 months

    Time from treatment initiation to first documented disease progression or death from any cause, whichever occurs first.

  4. Time to Treatment Discontinuation (TTD)

    Time frame: From treatment initiation up to 12 months

    Time from treatment initiation to discontinuation of therapy for any reason, including toxicity, disease progression, or patient/physician decision.

  5. Overall Survival (OS)

    Time frame: Minimum 12-month follow-up after diagnosis

    Time from date of diagnosis to death from any cause, based on real-world clinical follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Louisa ISSIAKHEM LOUNICI, CEO

CONTACT

[email protected]

+213 770 48 43 36

Sponsors and collaborators

Lead sponsor

Société Algérienne de Formation et de Recherche en Oncologie

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Observational Study of the Epidemiological, Clinical, and Diagnostic Profile, Treatment Patterns, and Outcomes of Lung Cancer.

Acronym: SAFRO2202

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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