Differentiated Thyroid CarcinomaMOLTHYNCT04970134
Spanish Study for Molecular Characterization of Thyroid Carcinoma
An observational study of Differentiated Thyroid Carcinoma and Medullary Thyroid Carcinoma, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 12 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Carcinoma, Medullary Thyroid Carcinoma
- What is being tested?
- Immunohistochemistry (IHC), Fluorescence In-Situ Hybridization (FISH) and Oncomine Focus Assay Platform with 52 genes
- How many people
- 150 participants
- Where
- 12 sitesSpain
- Study dates
- 14 Jun 2021to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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:
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- 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.
Who cannot join
- 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, ...).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Institut Català d'Oncologia Girona - ICO Girona
Girona, Girona, 17007
Hospital Universitario Durán i Reinals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario La Paz
Madrid, Madrid, 28046
Fundació Althaia
Manresa, Barcelona, 08243
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
Hospital universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
Official title: 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.
Read the 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).
- Being tested
- Immunohistochemistry (IHC), Fluorescence In-Situ Hybridization (FISH), Oncomine Focus Assay Platform with 52 genes
- Keywords
- advanced and/or metastatic disease, iodine refractory
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry (IHC)Other
VENTANA pan-TRK technique (EPR17341) Assay, with Optiview DAB-detection kit and Optiview amplification kit. Using FFPE slices
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)
Oncomine Focus Assay Platform with 52 genesOther
Also called Next Generation Sequencing (NGS)
Oncomine Focus Assay Platform with 52 genes (35 Hotspot genes, 19 Copy number variants and 23 Gene fusions). Using FFPE slices
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Immunohistochemistry (IHC); Other: Fluorescence In-Situ Hybridization (FISH); Other: Oncomine Focus Assay Platform with 52 genes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Throughout the study. Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start14 Jun 2021
- Primary completion25 Jan 2023
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neus Basté Rotllan, M.D. Ph.D., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970134
- Sponsor's protocol ID
- TTCC-2020-02
- Acronym
- MOLTHY
- Status last verified
- Sep 2024
- First submitted
- 16 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Observational Study for MOLecular Characterization of THYroid Carcinoma MOLTHY Project
- ClinicalTrials.gov ID
- NCT04970134
- Acronym / sponsor ID
- MOLTHY / TTCC-2020-02
- Keywords
- advanced and/or metastatic disease, iodine refractory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y CuelloUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid carcinoma | – | Other: Immunohistochemistry (IHC), Other: Fluorescence In-Situ Hybridization (FISH), Other: Oncomine Focus Assay Platform with 52 genesAdvanced 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (3 listed)
- 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, ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry (IHC)VENTANA pan-TRK technique (EPR17341) Assay, with Optiview DAB-detection kit and Optiview amplification kit. Using FFPE slices | Other | Thyroid carcinoma |
| 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 | Thyroid carcinoma |
| Oncomine Focus Assay Platform with 52 genesAlso: Next Generation Sequencing (NGS)Oncomine Focus Assay Platform with 52 genes (35 Hotspot genes, 19 Copy number variants and 23 Gene fusions). Using FFPE slices | Other | Thyroid carcinoma |
Primary outcome
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neus Basté Rotllan, M.D. Ph.D. principal investigator
Hospital Clinic of Barcelona
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Carcinoma and Medullary Thyroid Carcinoma, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Throughout the study. Approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.