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Lung NeoplasmsSAFRO2202NCT07161882

ALG-LungCancerRegistry (SAFRO2202)

An observational study of Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Société Algérienne de Formation et de Recherche en Oncologie at 21 sites in Algeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational Data Collection
How many people
3,750 participants
Where
21 sitesAlgeria
Study dates
1 Jun 2025to Dec 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Louisa ISSIAKHEM LOUNICI, CEO contact

+213 770 48 43 36

l.issiakhem@cmsolutionsdz.com

21 sites in 1 country

Algeria21 sites, 21 recruiting
  • Centre Pierre et Marie Curie

    Algiers, Algiers Province, 16000

    Esma KERBOUA, MD, +213 770 86 81 10, esmakerboua@yahoo.fr

    Esma KERBOUA, Professor of Medical Oncology

    Recruiting
  • Chu Beni Messous - Isaad Hassani

    Algiers, Algiers Province, 16000

    Merzak GHARNAOUT, MD, +213 561 27 06 89, mergharnaout@yahoo.fr

    Merzak GHARNAOUT, Professor of Pulmonology

    Recruiting
  • CHU Mohamed Lamine Debaghine - Bab-el-Oued

    Algiers, Algiers Province, 16000

    Souad SOUILAH, MD, +213 550 39 62 70, souad.souilah@gmail.com

    Souad SOUILAH, Professor of Pulmonology

    Recruiting
  • Chu-Beni Messous - Isaad Hassani

    Algiers, Algiers Province, 16000

    Mohammed OUKKAL, MD, +213 771 446 908, mohammedoukkal@gmail.com

    Mohammed OUKKAL, Professor of Medical Oncology

    Recruiting
  • EPH Rouiba

    Algiers, Algiers Province, 16000

    Hassen MAHFOUF, MD, +213 550 59 40 60, mahfoufhassen@gmail.com

    Hassen MAHFOUF, Professor of Medical Oncology

    Recruiting
  • CLCC Annaba

    Annaba, Annaba, 23000

    Hanène DJEDI, MD, +213 550 52 40 38, djedi_hanene@yahoo.fr

    Hanène DJEDI, Professor of Medical Oncology

    Recruiting
  • CLCC Batna

    Batna City, Batna

    Wassila BENBRAHIM, MD, +213 663 373 369, w.khemilet@gmail.com

    Wassila BENBRAHIM, Professor of Medical Oncology

    Recruiting
  • CHU- Hôpital Khelil Amrane

    Béjaïa, Béjaia Province, 06000

    Chahira MAZOUZI, MD, +213 553 68 20 71, shala_gouri@hotmail.com

    Chahira MAZOUZI, Professor of Medical Oncology

    Recruiting
  • CAC-CHU Frantz Fanon

    Blida, Blida Province

    Adda BOUNEDJAR, MD, +213 661 651 010, a_bounedjar@yahoo.fr

    Adda BOUNEDJAR, Professor of Medical Oncology

    Recruiting
  • CHU Dr Abdesselam Benbadis

    Constantine, Constantine Province, 25000

    Taha FILALI, MD, +213 671 69 60 75, tahafilali@gmail.com

    Taha FILALI, Professor of Medical Oncology

    Recruiting
  • EH Didouche Mourad

    Constantine, Constantine Province, 25000

    Assia BENSALEM, MD, +213 661 51 44 88, assiabensalem@yahoo.fr

    Assia BENSALEM, Professor of Medical Oncology

    Recruiting
  • CAC El OUED

    El Oued, Oued Souf, 39000

    Ahmed Zaki SADANI, MD, +213 771 446 908, time2@hotmail.fr

    Ahmed Zaki SADANI, Professor of Medical Oncology

    Recruiting
  • CAC-Laghouat

    Laghouat, Laghouat Province, 03000

    Zakia Batoul BENLAHRECH, MD, +213 657 325 700, z.benlahrech@lagh-univ.dz

    Zakia Batoul BENLAHRECH, Professor of Medical Oncology

    Recruiting
  • CAC Oran EL HASSI- EMIR ABDELKADER

    Oran, Oran Province, 31000

    Blaha LARBAOUI, MD, +213 560 33 02 01, larbaoui_onco@yahoo.fr

    Blaha LARBAOUI, Professor of Medical Oncology

    Recruiting
  • CHU Dr. Benaouda Benzerdjeb

    Oran, Oran Province, 31000

    Abdelkader BOUSAHBA, MD, +213 559 85 56 93, aekbousahba@yahoo.fr

    Abdelkader BOUSAHBA, Professor of Medical Oncology

    Recruiting
  • EHS 1er novembre

    Oran, Oran Province, 31000

    Faiza BEREKSI REGUIG, MD, +213 662 69 80 78, faizabereksireguig@yahoo.fr

    Faiza BEREKSI REGUIG, Professor of Medical Oncology

    Recruiting
  • CAC- Ouargla

    Ouargla, Ouargla Province, 30000

    Hanina FIZI, MD, +213 775 18 23 50, haninaf@yahoo.fr

    Hanina FIZI, Medical Oncologist

    Recruiting
  • CAC-Sétif

    Sétif, Sétif Province, 19000

    Hussein Adlane DIB, MD, +213 770 915 912, oncosetif@gmail.com

    Hussein Adlane DIB, Professor of Medical Oncology

    Recruiting
  • CAC- Sidi Bel Abbès

    Sidi Bel Abbes, Sidi Bel Abbès Province, 22000

    Djamila YEKROU, MD, +213 549 79 11 28, djyekrou@yahoo.fr

    Djamila YEKROU, Professor of Medical Oncology

    Recruiting
  • EPH- Sidi Ghiles

    Tipasa, Sidi Ghiles, 42115

    Fatma SEGHIER, MD, +213 540 464 853, seghierfatma@yahoo.fr

    Fatma SEGHIER, Professor of Medical Oncology

    Recruiting
  • CLCC Draâ Ben Khedda

    Tizi Ouzou, Draâ Ben Khedda, 15100

    Cherifa SEDKAOUI, MD, +213 552 05 00 65, csedkaoui@yahoo.fr

    Cherifa SEDKAOUI, Professor of Medical Oncology

    Recruiting

Other trials in Algeria

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
Observational Data Collection
Keywords
Lung Cancer, Non-Small Cell Lung Cancer, Carcinoid Tumor, Treatment Outcomes, Drug-Related Side Effects, Registries, Algeria
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Carcinoid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational Data CollectionOther

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

Study groups in NCT07161882
Study groupRoleWhat they receive
Lung Cancer Patients CohortAdult 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.
Receives: Other: Observational Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: At baseline (inclusion)

  4. First-line treatment modalities

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

    Measured: At baseline (initiation of treatment)

Secondary outcomes (5)
  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.

    Measured: From treatment initiation up to 12 months

  2. 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.

    Measured: From treatment initiation up to 12 months

  3. Progression-Free Survival (PFS)

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

    Measured: From treatment initiation up to 12 months

  4. Time to Treatment Discontinuation (TTD)

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

    Measured: From treatment initiation up to 12 months

  5. Overall Survival (OS)

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

    Measured: Minimum 12-month follow-up after diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start1 Jun 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,750 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161882
Sponsor's protocol ID
013/SAF/OBS/EPD/2024
Other IDs
SAFRO 2202
Acronym
SAFRO2202
Status last verified
Aug 2025
First submitted
25 Jun 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Société Algérienne de Formation et de Recherche en Oncologie at 21 sites in Algeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Louisa ISSIAKHEM LOUNICI, CEO (+213 770 48 43 36, l.issiakhem@cmsolutionsdz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sociodemographic and clinical characteristics of lung cancer patients in Algeria (time frame: At baseline (inclusion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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