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

N/AActive Not RecruitingNCT06876402

Hellenic Cooperative Oncology Group367 enrolled

Overview

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).

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

367

Conditions

NSCLC (Non-small Cell Lung Cancer)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hellenic Cooperative Oncology Group (HeCOG)

Athens, Greece

Outcomes

Primary Outcomes

OS (overall survival) in whole cohort.

Overall survival is defined from the date of initial diagnosis until death or last contact.

Time frame: Through study completion, 3 years.

Secondary Outcomes

Progression-free survival (PFS) in patients who received 1st line treatment for metastatic non-small cell ling cancer (NSCLC).

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.

Time frame: Through study completion, 3 years.

Recurrence-free survival (RFS) in patients who underwent surgical treatment for non-small cell lung cancer (NSCLC).

Recurrence-free survival is defined from the date of initial surgical diagnosis until the date of radiologically confirmed disease recurrence, following surgical resection.

Time frame: Through study completion, 3 years.

Data from ClinicalTrials.gov

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