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NCT Number: NCT06876402

Gene Molecular Alterations as Disease Prognostic Markers 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).

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Key information

Conditions

NSCLC (Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hellenic Cooperative Oncology Group (HeCOG)

Athens, 11526, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Prognostic value of assessed PD-L1 expression.

    Time frame: Through study completion, 3 years.

    Assessment of the prognostic value of PD-L1 expression.

  4. Prognostic value of tumor-infiltrating lymphocytes (TILs).

    Time frame: Through study completion, 3 years.

    Assessment of the prognostic value of tumor-infiltrating lymphocytes (TILs).

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

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)

Acronym: GEMA-proN

Important dates

Study start
2013
Primary completion
2024
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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