ALG-LungCancerRegistry (SAFRO2202)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Sociodemographic and clinical characteristics of lung cancer patients in Algeria [Срок оценки: At baseline (inclusion)]
• Histological type and stage of lung cancer at diagnosis [Срок оценки: At baseline (diagnosis/inclusion)]
• Molecular profile of tumors [Срок оценки: At baseline (inclusion)]
• First-line treatment modalities [Срок оценки: At baseline (initiation of treatment)]

Вторичные конечные точки (5)

• Treatment-related toxicity according to CTCAE [Срок оценки: From treatment initiation up to 12 months]
• Objective Response Rate (ORR) [Срок оценки: From treatment initiation up to 12 months]
• Progression-Free Survival (PFS) [Срок оценки: From treatment initiation up to 12 months]
• Time to Treatment Discontinuation (TTD) [Срок оценки: From treatment initiation up to 12 months]
• Overall Survival (OS) [Срок оценки: Minimum 12-month follow-up after diagnosis]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Algeria · 21 центр

• Centre Pierre et Marie Curie — Algiers
• Chu Beni Messous - Isaad Hassani — Algiers
• CHU Mohamed Lamine Debaghine - Bab-el-Oued — Algiers
• Chu-Beni Messous - Isaad Hassani — Algiers
• EPH Rouiba — Algiers
• CLCC Annaba — Annaba
• CLCC Batna — Batna City
• CAC-CHU Frantz Fanon — Blida
• … и ещё 13 центров

Идентификаторы

NCT: NCT07161882 · 013/SAF/OBS/EPD/2024 · SAFRO 2202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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