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

Hellenic Cooperative Oncology Group

Status: Active, not recruiting

Conditions: NSCLC (Non-small Cell Lung Cancer)

Study type: Observational

Funder types: Other

Identifiers

NCT06876402

HE_2TR/13

Details and patient eligibility

About

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).

Full 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.

Enrollment: 367 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

367 participants in 1 patient group

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

Description:

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.