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

NCT06876402 | Active Not Recruiting

• 1 other identifier: HE_2TR/13
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

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).

Conditions

NSCLC (Non-small Cell Lung Cancer)

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

Outcome Measures

Primary Outcomes (1)

• OS (overall survival) in whole cohort.

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

  Through study completion, 3 years.

Secondary Outcomes (2)

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

  Through study completion, 3 years.

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

  Through study completion, 3 years.

Other Outcomes (4)

• Prevalence of somatic gene alterations.

  Through study completion, 3 years.

• Prognostic value of assessed somatic gene molecular alterations.

  Through study completion, 3 years

• Prognostic value of assessed PD-L1 expression.

  Through study completion, 3 years.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Cooperative Oncology Group (HeCOG)

Athens, 11526, Greece

Location

Related Publications (5)

• Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature. 2014 Jul 31;511(7511):543-50. doi: 10.1038/nature13385. Epub 2014 Jul 9.

  PMID: 25079552 BACKGROUND

• Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012 Sep 27;489(7417):519-25. doi: 10.1038/nature11404. Epub 2012 Sep 9.

  PMID: 22960745 BACKGROUND

• Skoulidis F, Heymach JV. Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy. Nat Rev Cancer. 2019 Sep;19(9):495-509. doi: 10.1038/s41568-019-0179-8. Epub 2019 Aug 12.

  PMID: 31406302 BACKGROUND

• Hendry S, Salgado R, Gevaert T, Russell PA, John T, Thapa B, Christie M, van de Vijver K, Estrada MV, Gonzalez-Ericsson PI, Sanders M, Solomon B, Solinas C, Van den Eynden GGGM, Allory Y, Preusser M, Hainfellner J, Pruneri G, Vingiani A, Demaria S, Symmans F, Nuciforo P, Comerma L, Thompson EA, Lakhani S, Kim SR, Schnitt S, Colpaert C, Sotiriou C, Scherer SJ, Ignatiadis M, Badve S, Pierce RH, Viale G, Sirtaine N, Penault-Llorca F, Sugie T, Fineberg S, Paik S, Srinivasan A, Richardson A, Wang Y, Chmielik E, Brock J, Johnson DB, Balko J, Wienert S, Bossuyt V, Michiels S, Ternes N, Burchardi N, Luen SJ, Savas P, Klauschen F, Watson PH, Nelson BH, Criscitiello C, O'Toole S, Larsimont D, de Wind R, Curigliano G, Andre F, Lacroix-Triki M, van de Vijver M, Rojo F, Floris G, Bedri S, Sparano J, Rimm D, Nielsen T, Kos Z, Hewitt S, Singh B, Farshid G, Loibl S, Allison KH, Tung N, Adams S, Willard-Gallo K, Horlings HM, Gandhi L, Moreira A, Hirsch F, Dieci MV, Urbanowicz M, Brcic I, Korski K, Gaire F, Koeppen H, Lo A, Giltnane J, Rebelatto MC, Steele KE, Zha J, Emancipator K, Juco JW, Denkert C, Reis-Filho J, Loi S, Fox SB. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non-Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors. Adv Anat Pathol. 2017 Nov;24(6):311-335. doi: 10.1097/PAP.0000000000000161.

  PMID: 28777143 BACKGROUND

• Tuminello S, Sikavi D, Veluswamy R, Gamarra C, Lieberman-Cribbin W, Flores R, Taioli E. PD-L1 as a prognostic biomarker in surgically resectable non-small cell lung cancer: a meta-analysis. Transl Lung Cancer Res. 2020 Aug;9(4):1343-1360. doi: 10.21037/tlcr-19-638.

  PMID: 32953509 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA extraction from formalin fixed paraffin-embeded tissue (FFPE). 2 blocks, 5 sections per patient.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: September 9, 2013
• Primary Completion: October 13, 2024
• Study Completion: May 15, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)