Clinical trial · Observational
Tissue Microarrays (TMAs) Construction in Lung Cancer Samples
Evaluation of the Prognostic and Predictive Significance of EGFR, Kirsten Rat Sarcoma (KRAS), Anaplastic Lymphoma Kinase , Programmed Death-Ligand 1 (PD-L1) Protein and Microsatellite Instability (MSI) in Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Construction of a large cohort of lung cancer patients to evaluate the Prognostic and Predictive Significance of the molecular biomarkers Epidermal growth factor receptor (EGFR), KRAS, Anaplastic lymphoma kinase (EML4-ALK), Programmed Death-Ligand 1 (PD-L1) protein and Microsatellite Instability (MSI) in lung cancer: A tissue microarray-based study of 500 cases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- A translational research study of exploratory and descriptive nature of biomarkers in patients with lung cancer
- timeFrame
- The study is expected to start in the first quarter of 2016 and to end by the second quarter of 2019.
- description
- 500 cases will be studied. Three TMAs in total of lung adenocarcinoma, non-adenocarcinoma and SCLC, respectively- will be constructed. IHC for PD-L1 will be performed using commercially available antibodies and automated procedure. The EGFR, KRAS, ALK and MSI status will be assessed using routine molecular assays and procedures, either on the original FFPE tissue blocks or the constructed TMAs. MSI status will be evaluated using PCR-based method in FFPE tissue blocks. If that is not possible the status will be evaluate using IHC for the mismatch repair genes (MMR) hMLH1 and hMSH2 proteins expression on the TMAs. Biomarker characterization will be done according to the method that it will be used. For PD-L1: positive versus negative, for EGFR: mutant versus wild-type, for KRAS: mutant versus wild-type, for ALK: positive for ALK rearrangement versus negative for ALK rearrangement and for MSI: MSI high, MSI low, MSI stable.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Age \>18 years at study enrollment 3. Histologically confirmed NSCLC or SCLC 4. Availability of and access to patients' medical records containing demographic, clinical and treatment data as of lung cancer diagnosis and until the date of patient registration in the study. 5. Representative formalin-fixed paraffin-embedded tissue blocks. Exclusion Criteria: 1. Significant life-limiting comorbidity (such as end-stage cardiac, renal, pulmonary or liver disease) 2. Second concomitant malignancy or prior history of other malignancies 3. Known immunodeficiency .
References
Publications (0)
Data not yet available