Gene Molecular Alterations as Disease Prognostic Markers in Patients With Non-small Cell Lung Cancer (NSCLC) (GEMA-proN)

May 20, 2025 updated by: Hellenic Cooperative Oncology Group

Assessment of the Prevalence and Prognostic Value of Gene Molecular Alterations and Association With Clinicopathological Factors in Patients With Non-small Cell Lung Cancer (NSCLC)

GEMA-proN is an observational, multicenter, single cohort, retrospective clinical trial. The aim of the trial is to assess the prevalence, and prognostic value of genetic molecular alterations and investigate correlations with clinicopathological features in unselected patients with histologically confirmed non-small cell lung cancer (NSCLC).

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This a non- interventional, multicenter, retrospective one arm trial assessing patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC). Patients received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece between 2000 and 2020. Molecular genetic alterations, including single nucleotide variants, copy number alterations, and translocations, are detected with next generation sequencing using the ForeSENTIA® NSCLC panel developed by NIPD Genetics. The aim of the trial is to assess the prevalence and prognostic value of molecular alterations in the study population.

Study Type

Observational

Enrollment (Actual)

367

Contacts and Locations

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

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Hellenic Cooperative Oncology Group (HeCOG)

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with non-small cell lung cancer (NSCLC) regardless of disease stage, between 2000 and 2020, who received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece.

Variables under investigation;

  • ECOG performance status (categorical),
  • Sex (categorical)
  • Age (continuous)
  • Smoking status (categorical)
  • Histology type (categorical)
  • Stage (categorical)
  • Type of surgery in resected disease (categorical)
  • Pathogenic/ likely pathogenic SNVs (categorical)
  • CNAs (categorical)
  • Translocations (categorical)
  • Co-mutations (categorical)
  • PD-L1 expression (categorical)
  • TILs expression (categorical)
  • Immunotherapy in the 1st line setting (categorical)
  • Overall survival (OS) (continuous)
  • PFS (progression-free survival)
  • DFS (disease-free survival)

Description

Inclusion Criteria:

  • Age 18 and above.
  • Histologically confirmed non-small cell lung cancer (NSCLC).
  • Adequate, and suitable tissue for the testing of somatic genetic alterations.

Exclusion Criteria:

- Patients with personal medical history of malignancy, other than non-small cell lung cancer (NSCLC), with the exclusion of completely resected non-melanoma skin cancers, in situ carcinomas of the cervix uteri, in situ bladder carcinomas, in situ ductal breast carcinoma, and other cancers treated with curative intent with no evidence of disease recurrence for 5 years.

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
Patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).

Assessment of tumor molecular profile in patients with histologically confirmed early stage or metastatic non-small cell lung cancer (NSCLC).

Identification of gene somatic alterations including single nucleotide variants (SNVs), small insertions and deletions (indels), copy number alterations (CNAs), and rearrangements with the use of next generation sequencing (NGS) with a custom tumor profile gene assay developed by NIPD Genetics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS (overall survival) in whole cohort.
Time Frame: Through study completion, 3 years.
Overall survival is defined from the date of initial diagnosis until death or last contact.
Through study completion, 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) in patients who received 1st line treatment for metastatic non-small cell ling cancer (NSCLC).
Time Frame: Through study completion, 3 years.
Progression-free survival is defined from the date of 1st line treatment initiation until the date of radiologically confirmed disease progression (PD), following 1st line treatment.
Through study completion, 3 years.
Recurrence-free survival (RFS) in patients who underwent surgical treatment for non-small cell lung cancer (NSCLC).
Time Frame: Through study completion, 3 years.
Recurrence-free survival is defined from the date of initial surgical diagnosis until the date of radiologically confirmed disease recurrence, following surgical resection.
Through study completion, 3 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of assessed somatic gene molecular alterations.
Time Frame: Through study completion, 3 years
Assessment of the prognostic value of detected pathogenic/ likely pathogenic single nucleotide variants (SNVs), copy number alterations (CNAs), translocations, and co-mutations.
Through study completion, 3 years
Prevalence of somatic gene alterations.
Time Frame: Through study completion, 3 years.
Assessment of the prevalence of detected pathogenic/ likely pathogenic single nucleotide variants (SNVs), copy number alterations (CNAs), translocations, and co-mutations.
Through study completion, 3 years.
Prognostic value of assessed PD-L1 expression.
Time Frame: Through study completion, 3 years.
Assessment of the prognostic value of PD-L1 expression.
Through study completion, 3 years.
Prognostic value of tumor-infiltrating lymphocytes (TILs).
Time Frame: Through study completion, 3 years.
Assessment of the prognostic value of tumor-infiltrating lymphocytes (TILs).
Through study completion, 3 years.

Collaborators and Investigators

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

Sponsor

Hellenic Cooperative Oncology Group

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)

September 9, 2013

Primary Completion (Actual)

October 13, 2024

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE_2TR/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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