NSCLC (Non-small Cell Lung Cancer)
Conditions
Keywords
NSCLC, Non-small cell lung cancer, Early stage non-small cell lung cancer, Metastatic non-small cell lung cancer, Mutations, Copy number alterations, Translocations, CNA, PD-L1 expression, Tumor infiltrating lymphocytes, TILs, Pathogenic single nucleotide variants
Brief summary
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).
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.
Interventions
None listed
Sponsors
Hellenic Cooperative Oncology Group
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS (overall survival) in whole cohort. | Through study completion, 3 years. | Overall survival is defined from the date of initial diagnosis until death or last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) in patients who received 1st line treatment for metastatic non-small cell ling cancer (NSCLC). | 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. |
| Recurrence-free survival (RFS) in patients who underwent surgical treatment for non-small cell lung cancer (NSCLC). | 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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of somatic gene alterations. | 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. |
| Prognostic value of tumor-infiltrating lymphocytes (TILs). | Through study completion, 3 years. | Assessment of the prognostic value of tumor-infiltrating lymphocytes (TILs). |
| Prognostic value of assessed somatic gene molecular alterations. | 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. |
| Prognostic value of assessed PD-L1 expression. | Through study completion, 3 years. | Assessment of the prognostic value of PD-L1 expression. |
Countries
Greece
Outcome results
None listed