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NCT04970134

Spanish Study for Molecular Characterization of Thyroid Carcinoma

Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

View on ClinicalTrials.gov

Summary

This project is a retrospective observational study based on the molecular characterization of a Spanish population of patients with refractory radio-iodine differentiated thyroid cancer (DTC) and medullary thyroid carcinoma (MTC) with advanced and / or metastatic disease undergoing systemic treatment, or under clinical observation. Three diagnostic techniques will be performed on formalin-fixed paraffin embedded (FFPE) tumor samples from the study population: immunohistochemistry (IHC), fluorescence by in situ hybridization (FISH) as well as Next-Generation Sequencing (NGS) techniques by means of DNA and RNA analysis (Ion Platform Torrent - Oncomine Focus Assay, 52 gene detection). The results of each patient will be compared in order to correlate the results of each method.

Official title: Spanish Observational Study for MOLecular Characterization of THYroid Carcinoma MOLTHY Project

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2021-06-14

Completion Date

2025-03

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

OTHER

Immunohistochemistry (IHC)

VENTANA pan-TRK technique (EPR17341) Assay, with Optiview DAB-detection kit and Optiview amplification kit. Using FFPE slices

OTHER

Fluorescence In-Situ Hybridization (FISH)

FISH using FFPE slices for genes: Neurotrophic tyrosin kinase 1 (NTRK1), Neurotrophic tyrosin kinase 3 (NTRK3) and rearranged during transfection (RET)

OTHER

Oncomine Focus Assay Platform with 52 genes

Oncomine Focus Assay Platform with 52 genes (35 Hotspot genes, 19 Copy number variants and 23 Gene fusions). Using FFPE slices

Locations (12)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario Durán i Reinals

L'Hospitalet de Llobregat, Barcelona, Spain

Fundació Althaia

Manresa, Barcelona, Spain

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Hospital universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Institut Català d'Oncologia Girona - ICO Girona

Girona, Girona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain