Spanish Study for Molecular Characterization of Thyroid Carcinoma (MOLTHY)

April 19, 2023 updated by: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Spanish Observational Study for MOLecular Characterization of THYroid Carcinoma MOLTHY Project

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: A responsible person designated by the sponsor
  • Phone Number: 0034 934344412
  • Email: investigacion@mfar.net

Study Contact Backup

  • Name: Maria Luisa Duran Sanchez, Clinical Research Coordinator (TTCC)
  • Phone Number: 0034 690756714
  • Email: mduran@ttccgrupo.com

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia Girona - ICO Girona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Santander, Spain, 39008
        • Hospital Universitario Marques De Valdecilla
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Hospital Universitario Durán i Reinals
      • Manresa, Barcelona, Spain, 08243
        • Fundacio Althaia
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí de Sabadell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

It is estimated to include 150 patients over 18 years of age with thyroid carcinoma (radioiodine resistant differentiated thyroid carcinoma and medullary thyroid carcinoma) undergoing systemic treatment or under clinical follow-up.

Description

Inclusion Criteria:

  1. All participants must be over 18 years old
  2. Obtaining the informed consent signed by the patient or his legal representative.
  3. Have a paraffinized tumor sample available for analysis in the central laboratory, preferably from total thyroidectomy.
  4. Life expectancy greater than 6 months.
  5. 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:

  1. Patients with advanced / metastatic disease in wait & see follow-up.
  2. 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, ...
  3. 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:

  1. Patients affected by other malignant histologies not mentioned in the previous section (eg melanoma, lymphoma, sarcoma, ...) or benign tumors exclusively of the thyroid gland.
  2. Patients with radioiodine sensitive differentiated thyroid carcinoma or anaplastic thyroid carcinomas.
  3. 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, ...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid carcinoma

Advanced and / or metastatic thyroid carcinoma with initial histological diagnosis date before January 1, 2021 of the types:

Differentiated thyroid carcinoma (DTC) refractory to radio-iodine, including papillary carcinomas, follicular carcinomas, poorly differentiated carcinomas of the thyroid and the different corresponding variants.

Medullary thyroid carcinoma (MTC).
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
Other Names:
  • Next Generation Sequencing (NGS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Throughout the study. Approximately 2 years
Time from start of data capture (retrospectively) to progression disease. Patients may be stratified in subgroups attending to their histologic subtype and molecular genetic profile.
Throughout the study. Approximately 2 years
Overall survival (OS)
Time Frame: Throughout the study. Approximately 2 years
Time from start of data capture (retrospectively) to death. Patients may be stratified in subgroups attending to their histologic subtype and molecular genetic profile.
Throughout the study. Approximately 2 years
Objective response rate
Time Frame: Throughout the study. Approximately 2 years
Response to systemic treatments received if available. Patients may be stratified in subgroups attending to their histologic subtype and molecular genetic profile.
Throughout the study. Approximately 2 years
Prevalence of genetic alterations
Time Frame: Throughout the study. Approximately 2 years
Frequency of genetic alterations in the study population determined by the molecular genetic interventions: IHC, FISH and NGS
Throughout the study. Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Investigators

  • Principal Investigator: Neus Basté Rotllan, M.D. Ph.D., Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Actual)

January 25, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTCC-2020-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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