Clinical trial NCT05372081: Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer
Official title: Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4
Keywords: observational study
digital platform
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Stavros Niarchos Foundation
name: Care Across Ltd
First posted: 2022-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Non- Small Cell Lung Cancer candidates for 1st- line treatment (or previously having received adjuvant therapy), available FFPE tissue and blood sample and able to use a mobile device for basic digital communication

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.

Eligibility criteria: 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 Criteria:

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

Primary outcomes:
measure: Molecular identification of patients with non-small cell lung cancer
timeFrame: up to 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 36 months
measure: Data correlation
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Psychikó
country: Greece
facility: Ygeia Hospital
state: Attiki
city: Athens
country: Greece
facility: MITERA Hospital
state: Marousi
city: Larissa
country: Greece
facility: General University Hospital of Larissa
state: Mezourlo
city: Athens
country: Greece
facility: 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
state: Nea Kifisia
city: Athens
country: Greece
facility: 4th Dept of Medical Oncology, Metropolitan Hospital
state: Neo Faliro
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: EUROCLINIC of Athens
city: Athens
country: Greece
facility: 401 General Military Hospital of Athens
city: Athens
country: Greece
facility: 1st Dept of Medical Oncology, Metropolitan Hospital
city: Athens
country: Greece
facility: 2nd Dept of Medical Oncology, Metropolitan Hospital
city: Kavála
country: Greece
facility: General Hospital of Kavalas
city: Patra
country: Greece
facility: General Hospital of Patra "Agios Andreas"
city: Patra
country: Greece
facility: Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
city: Thessaloníki
country: Greece
facility: 2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki
city: Thessaloníki
country: Greece
facility: General Hospital of Thessalonikis "G. Papanikolaou"
Study officials:
affiliation: YGEIA Hospital
name: Paris Kosmidis, MD
role: PRINCIPAL_INVESTIGATOR
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