Spanish Study for Molecular Characterization of Thyroid Carcinoma (MOLTHY)

  • STATUS
    Recruiting
  • End date
    Mar 13, 2024
  • participants needed
    150
  • sponsor
    Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
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Updated on 13 April 2022
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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.

Description

Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) techniques will be carried out to identify NTRK and RET alterations. NTRK alterations will be identified using IHC techniques (NTRK over-expression), and FISH techniques (break-apart method). RET alterations will also be identified using the FISH technique (break-apart method).

At the same time, DNA and RNA will be extracted for sequencing techniques using the Oncomine Focus Assay platform, including 52 genes (35 Hotspot genes, 19 Copy number variants and 23 Gene fusions, including NTRK and RET).

Details
Condition Differentiated Thyroid Carcinoma, Medullary Thyroid Carcinoma
Treatment Immunohistochemistry (IHC), Fluorescence In-Situ Hybridization (FISH), Oncomine Focus Assay Platform with 52 genes
Clinical Study IdentifierNCT04970134
SponsorGrupo Español de Tratamiento de Tumores de Cabeza y Cuello
Last Modified on13 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

All participants must be over 18 years old
Obtaining the informed consent signed by the patient or his legal representative
Have a paraffinized tumor sample available for analysis in the central laboratory, preferably from total thyroidectomy
Life expectancy greater than 6 months
Thyroid carcinoma with a date of initial histological diagnosis before January 1, 2021 of the types
(1) Differentiated thyroid carcinoma (DTC) refractory to radio-iodine, including papillary
carcinomas, follicular carcinomas, poorly differentiated thyroid carcinomas, and the
corresponding different variants. The radio-refractoriness criteria will be defined by
medical criteria and / or by decision of the tumor committee (depending on the organization
of each hospital) or (2) Medullary thyroid carcinoma (MTC). 6. Potential candidate patients
must meet at least one of the following premises
Patients with advanced / metastatic disease in wait & see follow-up
Patients with advanced / metastatic disease currently undergoing treatment or in
progression to any type of multikinase inhibitor, such as, for example: sorafenib
lenvatinib, cabozantinib, axitinib, vandetanib
Patients with advanced / metastatic disease under treatment or in progression to
treatments that inhibit immune checkpoints (anti programed death (PD-1) or its ligand
(PD-L1), anti Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), others) or who are
participating in clinical trial regimen. They must be patients who have previously
progressed to multikinase inhibitors

Exclusion Criteria

Patients affected by other malignant histologies not mentioned in the previous section
(eg melanoma, lymphoma, sarcoma, ...) or benign tumors exclusively of the thyroid
gland
Patients with radioiodine sensitive differentiated thyroid carcinoma or anaplastic
thyroid carcinomas
Patients with refractory radioiodine differentiated thyroid carcinoma and advanced
medullary thyroid carcinomas with the possibility of local ablative treatment with
radical or curative intent (surgery, radiosurgery, radio-ablation, ...)
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