NCT07161882

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,750

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

Study Start

First participant enrolled

June 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 16, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

June 25, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

Lung CancerNon-Small Cell Lung CancerCarcinoid TumorTreatment OutcomesDrug-Related Side EffectsRegistriesAlgeria

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    At baseline (inclusion)

  • First-line treatment modalities

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

    At baseline (initiation of treatment)

Secondary Outcomes (5)

  • Treatment-related toxicity according to CTCAE

    From treatment initiation up to 12 months

  • Objective Response Rate (ORR)

    From treatment initiation up to 12 months

  • Progression-Free Survival (PFS)

    From treatment initiation up to 12 months

  • Time to Treatment Discontinuation (TTD)

    From treatment initiation up to 12 months

  • Overall Survival (OS)

    Minimum 12-month follow-up after diagnosis

Study Arms (1)

Lung Cancer Patients Cohort

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

Interventions

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

Lung Cancer Patients Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Age ≥ 18 years
  • Histologically confirmed diagnosis of lung cancer (NSCLC, SCLC, or carcinoid tumor)
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Centre Pierre et Marie Curie

Algiers, Algiers Province, 16000, Algeria

RECRUITING

Chu Beni Messous - Isaad Hassani

Algiers, Algiers Province, 16000, Algeria

RECRUITING

CHU Mohamed Lamine Debaghine - Bab-el-Oued

Algiers, Algiers Province, 16000, Algeria

RECRUITING

Chu-Beni Messous - Isaad Hassani

Algiers, Algiers Province, 16000, Algeria

RECRUITING

EPH Rouiba

Algiers, Algiers Province, 16000, Algeria

RECRUITING

CLCC Annaba

Annaba, Annaba, 23000, Algeria

RECRUITING

CLCC Batna

Batna City, Batna, Algeria

RECRUITING

CAC-CHU Frantz Fanon

Blida, Blida Province, Algeria

RECRUITING

CHU- Hôpital Khelil Amrane

Béjaïa, Béjaia Province, 06000, Algeria

RECRUITING

CHU Dr Abdesselam Benbadis

Constantine, Constantine Province, 25000, Algeria

RECRUITING

EH Didouche Mourad

Constantine, Constantine Province, 25000, Algeria

RECRUITING

CLCC Draâ Ben Khedda

Tizi Ouzou, Draâ Ben Khedda, 15100, Algeria

RECRUITING

CAC-Laghouat

Laghouat, Laghouat Province, 03000, Algeria

RECRUITING

CAC Oran EL HASSI- EMIR ABDELKADER

Oran, Oran Province, 31000, Algeria

RECRUITING

CHU Dr. Benaouda Benzerdjeb

Oran, Oran Province, 31000, Algeria

RECRUITING

EHS 1er novembre

Oran, Oran Province, 31000, Algeria

RECRUITING

CAC- Ouargla

Ouargla, Ouargla Province, 30000, Algeria

RECRUITING

CAC El OUED

El Oued, Oued Souf, 39000, Algeria

RECRUITING

CAC- Sidi Bel Abbès

Sidi Bel Abbes, Sidi Bel Abbès Province, 22000, Algeria

RECRUITING

EPH- Sidi Ghiles

Tipasa, Sidi Ghiles, 42115, Algeria

RECRUITING

CAC-Sétif

Sétif, Sétif Province, 19000, Algeria

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Small CellCarcinoid Tumor

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaNeoplasms, Nerve Tissue

Study Officials

  • Adda BOUNEDJAR, Professor of Medical Oncology

    Frantz Fanon University Hospital, Cancer Center (CAC), Blida, Algeria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louisa ISSIAKHEM LOUNICI, CEO

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

September 9, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 16, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations