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Clinical Trial Finder

Search Results

Spanish Study for Molecular Characterization of Thyroid Carcinoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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, ...).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04970134
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Neus Basté Rotllan, M.D. Ph.D.
Principal Investigator Affiliation Hospital Clinic of Barcelona
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Differentiated Thyroid Carcinoma, Medullary Thyroid Carcinoma
Additional Details

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).

Arms & Interventions

Arms

: 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).

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Universitario Vall d'Hebron, Barcelona 3128760, Barcelona, Spain

Status

Address

Hospital Universitario Vall d'Hebron

Barcelona 3128760, Barcelona, 08035

Hospital Clínic de Barcelona, Barcelona 3128760, Barcelona, Spain

Status

Address

Hospital Clínic de Barcelona

Barcelona 3128760, Barcelona, 08036

Hospital Universitario Durán i Reinals, L'Hospitalet de Llobregat 3120619, Barcelona, Spain

Status

Address

Hospital Universitario Durán i Reinals

L'Hospitalet de Llobregat 3120619, Barcelona, 08908

Fundació Althaia, Manresa 3117533, Barcelona, Spain

Status

Address

Fundació Althaia

Manresa 3117533, Barcelona, 08243

Sabadell 3111199, Barcelona, Spain

Status

Address

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell 3111199, Barcelona, 08208

Santander 3109718, Cantabria 3336898, Spain

Status

Address

Hospital universitario Marqués de Valdecilla

Santander 3109718, Cantabria 3336898, 39008

Girona 3121456, Girona, Spain

Status

Address

Institut Català d'Oncologia Girona - ICO Girona

Girona 3121456, Girona, 17007

Hospital Universitario Ramón y Cajal, Madrid 3117735, Madrid 3117732, Spain

Status

Address

Hospital Universitario Ramón y Cajal

Madrid 3117735, Madrid 3117732, 28034

Hospital Universitario La Paz, Madrid 3117735, Madrid 3117732, Spain

Status

Address

Hospital Universitario La Paz

Madrid 3117735, Madrid 3117732, 28046

Valencia 2509954, Valencia 2593113, Spain

Status

Address

Hospital General Universitario de Valencia

Valencia 2509954, Valencia 2593113, 46014

Valencia 2509954, Valencia 2593113, Spain

Status

Address

Hospital Universitario y Politécnico La Fe

Valencia 2509954, Valencia 2593113, 46026

Hospital Universitario Miguel Servet, Zaragoza 3104324, Zaragoza, Spain

Status

Address

Hospital Universitario Miguel Servet

Zaragoza 3104324, Zaragoza, 50009

Resources

  • Patient and Caregiver Survey
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  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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