Clinical trial · Observational
Spanish Study for Molecular Characterization of Thyroid Carcinoma
Spanish Observational Study for MOLecular Characterization of THYroid Carcinoma MOLTHY Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Carcinoma | Differentiated Thyroid Gland Carcinoma | ALIAS | 0.90 |
| Medullary Thyroid Carcinoma | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence In-Situ Hybridization (FISH) | Other | — | UNRESOLVED |
| Immunohistochemistry (IHC) | Other | — | UNRESOLVED |
| Oncomine Focus Assay Platform with 52 genes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Thyroid carcinoma
- description
- 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).
- interventionNames
- Other: Immunohistochemistry (IHC)
- Other: Fluorescence In-Situ Hybridization (FISH)
- Other: Oncomine Focus Assay Platform with 52 genes
Primary outcomes (4)
- measure
- Progression free survival (PFS)
- timeFrame
- Throughout the study. Approximately 2 years
- description
- 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.
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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, ...).
References
Publications (0)
Data not yet available