Spanish Study for Molecular Characterization of Thyroid Carcinoma

NCT04970134 | Active Not Recruiting DMC

• 1 other identifier: TTCC-2020-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Differentiated Thyroid Carcinoma; Medullary Thyroid Carcinoma

Keywords

advanced and/or metastatic disease; iodine refractory

Outcome Measures

Primary Outcomes (4)

• Progression free survival (PFS)

  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 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

  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

  Frequency of genetic alterations in the study population determined by the molecular genetic interventions: IHC, FISH and NGS

  Throughout the study. Approximately 2 years

Study Arms (1)

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); Other: Fluorescence In-Situ Hybridization (FISH); Other: Oncomine Focus Assay Platform with 52 genes

Interventions

Immunohistochemistry (IHC) OTHER

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

Thyroid carcinoma

Fluorescence In-Situ Hybridization (FISH) OTHER

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

Thyroid carcinoma

Oncomine Focus Assay Platform with 52 genes OTHER

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

Also known as: Next Generation Sequencing (NGS)

Thyroid carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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, ...).

Sponsors & Collaborators

• Grupo Español de Tratamiento de Tumores de Cabeza y Cuello: lead

Study Sites (12)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario Durán i Reinals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Fundació Althaia

Manresa, Barcelona, 08243, Spain

Location

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Hospital universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Institut Català d'Oncologia Girona - ICO Girona

Girona, Girona, 17007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor sample from each patient in formalin-fixed paraffin block (FFPE)

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

Immunohistochemistry; In Situ Hybridization, Fluorescence; High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Sequence Analysis

Study Officials

• Neus Basté Rotllan, M.D. Ph.D.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 21, 2021
• Study Start: June 14, 2021
• Primary Completion: January 25, 2023
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (12)