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

NCT05372081 | Unknown

• 1 other identifier: HE2SN/21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 15

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. 1.Clinical: personalized treatment will be administered and its effectiveness and safety will be recorded and evaluated.
2. 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. 3.Digital: Patients will have access to the digital platform where they will record the adverse reactions they will face during their treatment.

Conditions

Non-Small Cell Carcinoma of Lung, TNM Stage 4

Keywords

observational study; digital platform

Outcome Measures

Primary Outcomes (1)

• Molecular identification of patients with non-small cell lung cancer

  up to 36 months

Secondary Outcomes (2)

• Overall survival

  up to 36 months

• Data correlation

  up to 36 months

Study Arms (2)

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 who will not receive digital assistant

Patients will just include any symptoms/adverse events in their profile in the digital platform.

Other: Digital platform

Interventions

Digital platform OTHER

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 who will receive digital assistant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• Stavros Niarchos Foundation: collaborator
• Care Across Ltd: collaborator

Study Sites (15)

Ygeia Hospital

Psychikó, Attica, 15123, Greece

RECRUITING

MITERA Hospital

Athens, Marousi, 15123, Greece

RECRUITING

General University Hospital of Larissa

Larissa, Mezourlo, 41110, Greece

RECRUITING

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

Athens, Nea Kifisia, 14564, Greece

RECRUITING

4th Dept of Medical Oncology, Metropolitan Hospital

Athens, Neo Faliro, 18547, Greece

RECRUITING

Henry Dunant Hospital Center

Athens, 115 26, Greece

RECRUITING

EUROCLINIC of Athens

Athens, 11521, Greece

RECRUITING

401 General Military Hospital of Athens

Athens, 11525, Greece

RECRUITING

1st Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

RECRUITING

2nd Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

RECRUITING

General Hospital of Kavalas

Kavala, 65500, Greece

RECRUITING

General Hospital of Patra "Agios Andreas"

Pátrai, 26335, Greece

RECRUITING

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

Pátrai, 26504, Greece

RECRUITING

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

Thessaloniki, 54645, Greece

RECRUITING

General Hospital of Thessalonikis "G. Papanikolaou"

Thessaloniki, 57010, Greece

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and Formalin Fixed Paraffin Embedded tumour tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paris Kosmidis, MD

  YGEIA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paris Kosmidis, MD

CONTACT

+30 210 6867105; parkosmi@otenet.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: March 23, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 13, 2022

Record last verified: 2022-04

Locations

GR (15)