Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer

Last updated: May 12, 2022
Sponsor: Hellenic Cooperative Oncology Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05372081
HE2SN/21
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to provide high quality oncology services to patients with inoperable Non-Small Cell Lung Cancer (NSCLC) in Greece. These services will be based on 3 pillars:

  1. Clinical: personalized treatment will be administered and its effectiveness and safety will be recorded and evaluated.

  2. Molecular: the gene footprint of each patient at the beginning of his treatment, the molecular identity of his tumor will be analyzed and recorded based on analysis with modern Next Generation Sequencing (NGS) techniques.

  3. Digital: Patients will have access to the digital platform where they will record the adverse reactions they will face during their treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with non-small cell lung cancer stage IV
  • No younger than 18 years old patients
  • Performance status: 0-2
  • Existence of biological material for the molecular analysis
  • Patients who have not been treated with any other treatment than adjuvant
  • Ability to use a mobile device or computer for digital communication

Exclusion

Exclusion Criteria:

  • Childbearing women
  • Patients with PS > 3
  • Limited ability to use a mobile device for basic digital communication

Study Design

Total Participants: 200
Study Start date:
March 23, 2022
Estimated Completion Date:
March 31, 2025

Study Description

Lung cancer is the primary cause of cancer death worldwide regardless of gender or age group. Based on the most recent statistics for our country, every year about 9000 new cases of lung cancer are diagnosed. Lung cancer is the most common type of cancer in Greece in both men and women. It is estimated that about 8000 people lose their lives annually from this disease, while the total number of deaths from lung cancer seems to exceed in number the sum of deaths due to breast, prostate and colorectal cancer.

For many decades chemotherapy was the cornerstone and the only treatment option for lung cancer. In the last 20 years, the discovery and study of various molecular subtypes in non-small cell lung cancer has led to the development of targeted therapies. Modern oncology has multiple targeted therapies for corresponding molecular subtypes, such as ROS-1 rearrangements, amplifications and mutations of the MET gene, RET rearrangements, mutations of the BRAF gene, NTRK gene fusions, HER2 gene mutations, as well as KRAS mutations.The detection of molecular pathways, targeted mutations and biomarkers is a critical step in the diagnosis and treatment of patients with non-small cell lung cancer, in both early and advanced stage.The use of NGS (Next Generation Sequencing) technology as modern tool for accessing genetic material is adopted by more and more clinicians worldwide. The molecular analysis of the tumor with the technique of NGS, is considered as a necessity in the practice of modern oncology in order the patients to receive the best treatments for their disease.

a) Clinical pillar: In this study will be included 200 patients, 18 years old and older, with PS 0-2, treated for inoperable NSCLC stage IV. Patient will be treated according to the local standard of care based on their medical history. b)After signing the Informed Consent patients will provide biological material (blood samples and Formalin fixed paraffin embedded tissues) in order to proceed with the molecular arm of the study and the extended NGS analysis. In addition to molecular analysis, an economic analysis of the use of health resources will follow for a detailed understanding of the relevant financial aggregates and the improvement of the performance of existing resources. c) On the digital arm each patient will have access in the digital platform of CAREACCROSS which allows continuous and remote access for both patient and their physician with absolute security and data privacy.

All patients will be included in the digital monitoring and information program from their mobile phone and will have contact the investigator and the study team.

Connect with a study center

  • Ygeia Hospital

    Psychikó, Attiki 15123
    Greece

    Active - Recruiting

  • MITERA Hospital

    Athens, Marousi 15123
    Greece

    Active - Recruiting

  • General University Hospital of Larissa

    Larissa, Mezourlo 41110
    Greece

    Active - Recruiting

  • 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

    Athens, Nea Kifisia 14564
    Greece

    Active - Recruiting

  • 4th Dept of Medical Oncology, Metropolitan Hospital

    Athens, Neo Faliro 18547
    Greece

    Active - Recruiting

  • 1st Dept of Medical Oncology, Metropolitan Hospital

    Athens, 18547
    Greece

    Active - Recruiting

  • 2nd Dept of Medical Oncology, Metropolitan Hospital

    Athens, 18547
    Greece

    Active - Recruiting

  • 401 General Military Hospital of Athens

    Athens, 11525
    Greece

    Active - Recruiting

  • EUROCLINIC of Athens

    Athens, 11521
    Greece

    Active - Recruiting

  • Henry Dunant Hospital Center

    Athens, 115 26
    Greece

    Active - Recruiting

  • General Hospital of Kavalas

    Kavála, 65500
    Greece

    Active - Recruiting

  • Division of Oncology, Dept of Internal Medicine, University Hospital of Patras

    Patra, 26504
    Greece

    Active - Recruiting

  • General Hospital of Patra "Agios Andreas"

    Patra, 26335
    Greece

    Active - Recruiting

  • 2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki

    Thessaloníki, 54645
    Greece

    Active - Recruiting

  • General Hospital of Thessalonikis "G. Papanikolaou"

    Thessaloníki, 57010
    Greece

    Active - Recruiting

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