Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer (SNF-CLIMEDIN)

May 12, 2022 updated by: Hellenic Cooperative Oncology Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 115 26
        • Recruiting
        • Henry Dunant Hospital Center
        • Principal Investigator:
          • IOANNIS MOUNTZIOS
        • Contact:
      • Athens, Greece, 11521
        • Recruiting
        • Euroclinic of Athens
        • Contact:
        • Principal Investigator:
          • Christos Panopoulos, MD
      • Athens, Greece, 11525
        • Recruiting
        • 401 General Military Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Nikolaos Tsoukalas, MD
      • Athens, Greece, 18547
        • Recruiting
        • 1st Dept of Medical Oncology, Metropolitan Hospital
        • Contact:
        • Principal Investigator:
          • Dimitrios Bafaloukos, MD
      • Athens, Greece, 18547
        • Recruiting
        • 2nd Dept of Medical Oncology, Metropolitan Hospital
        • Contact:
        • Principal Investigator:
          • Epameinontas Samantas, MD
      • Kavála, Greece, 65500
        • Recruiting
        • General Hospital of Kavalas
        • Contact:
        • Principal Investigator:
          • Anastasios Vagionas
      • Patra, Greece, 26335
        • Recruiting
        • General Hospital of Patra "Agios Andreas"
        • Contact:
        • Principal Investigator:
          • Athina Christopoulou, MD
      • Patra, Greece, 26504
        • Recruiting
        • Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
        • Contact:
        • Principal Investigator:
          • Angelos Koutras, MD
      • Thessaloníki, Greece, 54645
        • Recruiting
        • 2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Eleni Fountzilas, MD
      • Thessaloníki, Greece, 57010
        • Recruiting
        • General Hospital of Thessalonikis "G. Papanikolaou"
        • Contact:
        • Principal Investigator:
          • Sofia Lampaki, MD
    • Attiki
      • Psychikó, Attiki, Greece, 15123
        • Recruiting
        • Ygeia Hospital
        • Contact:
        • Principal Investigator:
          • Paris Kosmidis, MD
    • Marousi
      • Athens, Marousi, Greece, 15123
        • Recruiting
        • Mitera Hospital
        • Contact:
        • Principal Investigator:
          • Ilias Athanasiadis, MD
    • Mezourlo
      • Larissa, Mezourlo, Greece, 41110
        • Recruiting
        • General University Hospital Of Larissa
        • Contact:
        • Principal Investigator:
          • Athansios Kotsakis, MD
    • Nea Kifisia
      • Athens, Nea Kifisia, Greece, 14564
        • Recruiting
        • 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Sgouros, MD
    • Neo Faliro
      • Athens, Neo Faliro, Greece, 18547
        • Recruiting
        • 4th Dept of Medical Oncology, Metropolitan Hospital
        • Contact:
        • Principal Investigator:
          • Elena Linardou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who will receive digital assistant
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.
Other: Digital platform
Patients will be randomized (1:1) in the way they will receive or not any assistance from the digital platform.
Patients who will not receive digital assistant
Patients will just include any symptoms/adverse events in their profile in the digital platform.
Other: Digital platform
Patients will be randomized (1:1) in the way they will receive or not any assistance from the digital platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Molecular identification of patients with non-small cell lung cancer
Time Frame: up to 36 months
up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 36 months
up to 36 months
Data correlation
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Collaborators

Stavros Niarchos Foundation
Care Across Ltd

Investigators

  • Principal Investigator: Paris Kosmidis, MD, Ygeia Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE2SN/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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