Tissue Microarrays (TMAs) Construction in Lung Cancer Samples

NCT03136523 | Completed

• 2 other identifiers: D5162C00012ESR-15-11047
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer

Keywords

NSCLC; SCLC; MOLECULAR BIOMARKERS; EGFR; PD-L1; ALK; KRAS

Outcome Measures

Primary Outcomes (1)

• A translational research study of exploratory and descriptive nature of biomarkers in patients with lung cancer

  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.

  The study is expected to start in the first quarter of 2016 and to end by the second quarter of 2019.

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

This study will be performed in a tertiary hospital and will include a cohort of patients, alive or deceased at the time of their registration in this study, with consecutive lung cancer diagnosis (adeno- and nonadeno- NSCLC and SCLC) between January 1, 2012 and December 31, 2015. A total number of 500 cases will be studied. The planned number of cases to be included in this translational study, has been estimated on the basis of the average actual number of lung cancer diagnoses handled by the Institutional pathological laboratory annually. The study populations will include 200 patients with lung adenocarcinoma, 150 patients with NSCLC (other than adenocarcinoma) and 150 patients with SCLC.

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Age \>18 years at study enrollment
• Histologically confirmed NSCLC or SCLC
• 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.
• Representative formalin-fixed paraffin-embedded tissue blocks.

You may not qualify if:

• Significant life-limiting comorbidity (such as end-stage cardiac, renal, pulmonary or liver disease)
• Second concomitant malignancy or prior history of other malignancies
• Known immunodeficiency .

Sponsors & Collaborators

• Kostas N.Syrigos: lead

Study Sites (1)

OCEBER

Athens, 11527, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples from small biopsies ( core needle biopsy, FNB, excisional biopsy, incisional biopsy) or surgical resection

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Konstantinos N Syrigos, MD,PhD

  Non-Governmental, Non-Profit Organization

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 2, 2017
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: September 28, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)