Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer
- Conditions
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
- Interventions
- Other: Digital platform
- Registration Number
- NCT05372081
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Childbearing women
- Patients with PS > 3
- Limited ability to use a mobile device for basic digital communication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who will not receive digital assistant Digital platform Patients will just include any symptoms/adverse events in their profile in the digital platform. Patients who will receive digital assistant Digital platform Patients will receive digital assistance (in a few words text format) for any symptoms/adverse events they will include in their profile in the digital platform.
- Primary Outcome Measures
Name Time Method Molecular identification of patients with non-small cell lung cancer up to 36 months
- Secondary Outcome Measures
Name Time Method Data correlation up to 36 months Overall survival up to 36 months
Trial Locations
- Locations (15)
General University Hospital of Larissa
🇬🇷Larissa, Mezourlo, Greece
Ygeia Hospital
🇬🇷Psychikó, Attiki, Greece
Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
🇬🇷Patra, Greece
3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
🇬🇷Athens, Nea Kifisia, Greece
EUROCLINIC of Athens
🇬🇷Athens, Greece
1st Dept of Medical Oncology, Metropolitan Hospital
🇬🇷Athens, Greece
MITERA Hospital
🇬🇷Athens, Marousi, Greece
401 General Military Hospital of Athens
🇬🇷Athens, Greece
General Hospital of Patra "Agios Andreas"
🇬🇷Patra, Greece
2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki
🇬🇷ThessalonÃki, Greece
4th Dept of Medical Oncology, Metropolitan Hospital
🇬🇷Athens, Neo Faliro, Greece
Henry Dunant Hospital Center
🇬🇷Athens, Greece
2nd Dept of Medical Oncology, Metropolitan Hospital
🇬🇷Athens, Greece
General Hospital of Kavalas
🇬🇷Kavála, Greece
General Hospital of Thessalonikis "G. Papanikolaou"
🇬🇷ThessalonÃki, Greece