Thyroid CancerTRAMTNCT06878534
Observational Study Analysing the Transcriptome and Mutational Status of Thyroid Carcinomas of Follicular Origin with Different Degrees of Malignancy
An observational study of Thyroid Cancer, run by IRCCS SYNLAB SDN at 1 site in Italy.
Trial summary
Thyroid cancer (TC) is the most common endocrine malignancy, with well-differentiated thyroid carcinomas (DTCs)-papillary (PTC) and follicular (FTC)-comprising the majority of cases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients with thyroid carcinoma originating from the follicular thyroid cell at varying degrees of malignancy. For such a retrospective population, considering the study's primary objective of identifying potential tissue biomarkers of pathology, an a posteriori power analysis was performed, considering a paired statistical design of the case-control type, where the control group is afferent to the healthy counterpart of the tissues available in the archives of the same thyroid carcinoma patients. For the subgroup analyses associated with the different degrees of invasiveness/aggressiveness, the statistical power associated with the possible clinical stratifications will be assessed before proceeding with the statistical analyses
Who may be able to join
- Patients of either sex aged > 18 years with thyroid cancer of follicular origin.
Who cannot join
- Patients who do not fit the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Pierri contact
Italy1 site, 1 recruiting
- Recruiting
Irccs Synlab Sdn
Naples, 80146
Laura Pierri, direzionescientifica.irccssdn@synlab.it
Laura Pierri, laura.pierri@synlab.it
About this study
Thyroid cancer (TC) is the most common endocrine malignancy, with well-differentiated thyroid carcinomas (DTCs)-papillary (PTC) and follicular (FTC)-comprising the majority of cases. While DTCs generally have favorable prognoses, a subset progresses to poorly differentiated or anaplastic thyroid carcinoma (ATC), which is highly aggressive. Tumor classification is based on histopathology, invasiveness, and molecular characteristics, with new entities like thyroid tumors of uncertain malignant potential (TT-UMP) and non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) refining diagnostic criteria.
Current standard treatments include surgical resection, radioactive iodine therapy, and thyroid hormone replacement. However, some patients develop radioiodine-refractory disease with an increased risk of recurrence and progression. Molecular alterations in the MAPK and PI3K pathways play critical roles in thyroid tumorigenesis, influencing therapeutic response and prognosis. Identifying novel biomarkers for early detection and risk stratification is crucial. Emerging evidence highlights the role of microRNAs (miRNAs) in thyroid cancer progression, functioning as oncogenes or tumor suppressors.
Read more
This retrospective case-control study aims to identify novel molecular markers linked to thyroid cancer aggressiveness. Archived formalin-fixed paraffin-embedded (FFPE) tissue and blood samples will be analyzed from patients with varying degrees of PTC and FTC invasiveness. Control samples will be histologically normal thyroid tissue from the same patients.
Next Generation Sequencing (NGS), including RNA-seq and miRNA-seq, will be employed to detect differentially expressed RNA molecules. Validation will be performed using Real-Time PCR in an independent cohort. High-throughput genomic sequencing (Illumina TruSight Oncology 500) will assess mutations, copy number variations, and tumor mutation burden to correlate genetic alterations with malignancy. Variants will be prioritized based on frequency differences in tumor vs. non-tumor populations and functional relevance.
The study will enroll patients with follicular cell-derived thyroid carcinoma. A power analysis indicates that 80 subjects provide >80% statistical power for biomarker identification. Descriptive statistics, parametric/non-parametric tests, and machine learning approaches will analyze transcriptomic and genomic data. Receiver operating characteristic (ROC) curves will assess diagnostic biomarker accuracy, while logistic regression will model associations between molecular alterations and disease severity.
This study aims to uncover molecular mechanisms driving thyroid cancer progression and identify biomarkers for improved risk stratification, early diagnosis, and potential therapeutic targeting. Findings may enhance personalized treatment approaches in thyroid oncology.
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, miRNA, non coding RNA
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid cancer patients | Patients with thyroid cancer | |
| Control subjects | Subjects with non-cancerous thyroid pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of novel molecular biomarkers associated with the progression and aggressiveness of follicular-derived thyroid carcinomas
RNA-seq and miRNA-seq on serum samples
Measured: 1-36 months
Determine genetic alterations hat may contribute to disease progression
Identification of mutations, copy number variations, and tumor mutation burden)
Measured: 1-36 months
Secondary outcomes (1)
Develop of predictive models for improved risk stratification and prognosis
Application of machine learning approach to integrate transcriptomic and genomic data
Measured: 12-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start13 Mar 2023
- Primary completion30 Jul 2024
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS SYNLAB SDN
- Sponsor type
- University, hospital or other
- Collaborators
- University Federico II of Naples, Department of Clinical and Surgical Medicine
- Responsible party
- Principal investigator, Marco Salvatore, IRCCS SYNLAB SDN
- Investigators
- Giovanni Smaldone, Principal investigator, IRCCS SYNLAB SDN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878534
- Sponsor's protocol ID
- 3/22
- Acronym
- TRAMT
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967Rossi ED, Locantore P, Bruno C, Dell'Aquila M, Tralongo P, Curatolo M, Revelli L, Raffaelli M, Larocca LM, Pantanowitz L, Pontecorvi A. Molecular Characterization of Thyroid Follicular Lesions in the Era of "Next-Generation" Techniques. Front Endocrinol (Lausanne). 2022 May 12;13:834456. doi: 10.3389/fendo.2022.834456. eCollection 2022.
PubMed 35634500Xu B, Fuchs T, Dogan S, Landa I, Katabi N, Fagin JA, Tuttle RM, Sherman E, Gill AJ, Ghossein R. Dissecting Anaplastic Thyroid Carcinoma: A Comprehensive Clinical, Histologic, Immunophenotypic, and Molecular Study of 360 Cases. Thyroid. 2020 Oct;30(10):1505-1517. doi: 10.1089/thy.2020.0086. Epub 2020 May 8.
PubMed 32284020Macerola E, Poma AM, Vignali P, Basolo A, Ugolini C, Torregrossa L, Santini F, Basolo F. Molecular Genetics of Follicular-Derived Thyroid Cancer. Cancers (Basel). 2021 Mar 7;13(5):1139. doi: 10.3390/cancers13051139.
PubMed 33799953Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Analysing the Transcriptome and Mutational Status of Thyroid Carcinomas of Follicular Origin with Different Degrees of Malignancy
- ClinicalTrials.gov ID
- NCT06878534
- Acronym / sponsor ID
- TRAMT / 3/22
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, miRNA, non coding RNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS SYNLAB SDNUniversity, hospital or other
- Collaborators
- University Federico II of Naples, Department of Clinical and Surgical Medicine
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Mar 2025 (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.
Thyroid cancer (TC) is the most common endocrine malignancy, with well-differentiated thyroid carcinomas (DTCs)-papillary (PTC) and follicular (FTC)-comprising the majority of cases. While DTCs generally have favorable prognoses, a subset progresses to poorly differentiated or anaplastic thyroid carcinoma (ATC), which is highly aggressive. Tumor classification is based on histopathology, invasiveness, and molecular characteristics, with new entities like thyroid tumors of uncertain malignant potential (TT-UMP) and non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) refining diagnostic criteria.
Current standard treatments include surgical resection, radioactive iodine therapy, and thyroid hormone replacement. However, some patients develop radioiodine-refractory disease with an increased risk of recurrence and progression. Molecular alterations in the MAPK and PI3K pathways play critical roles in thyroid tumorigenesis, influencing therapeutic response and prognosis. Identifying novel biomarkers for early detection and risk stratification is crucial. Emerging evidence highlights the role of microRNAs (miRNAs) in thyroid cancer progression, functioning as oncogenes or tumor suppressors.
This retrospective case-control study aims to identify novel molecular markers linked to thyroid cancer aggressiveness. Archived formalin-fixed paraffin-embedded (FFPE) tissue and blood samples will be analyzed from patients with varying degrees of PTC and FTC invasiveness. Control samples will be histologically normal thyroid tissue from the same patients.
Next Generation Sequencing (NGS), including RNA-seq and miRNA-seq, will be employed to detect differentially expressed RNA molecules. Validation will be performed using Real-Time PCR in an independent cohort. High-throughput genomic sequencing (Illumina TruSight Oncology 500) will assess mutations, copy number variations, and tumor mutation burden to correlate genetic alterations with malignancy. Variants will be prioritized based on frequency differences in tumor vs. non-tumor populations and functional relevance.
The study will enroll patients with follicular cell-derived thyroid carcinoma. A power analysis indicates that 80 subjects provide >80% statistical power for biomarker identification. Descriptive statistics, parametric/non-parametric tests, and machine learning approaches will analyze transcriptomic and genomic data. Receiver operating characteristic (ROC) curves will assess diagnostic biomarker accuracy, while logistic regression will model associations between molecular alterations and disease severity.
This study aims to uncover molecular mechanisms driving thyroid cancer progression and identify biomarkers for improved risk stratification, early diagnosis, and potential therapeutic targeting. Findings may enhance personalized treatment approaches in thyroid oncology.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid cancer patients | – | –Patients with thyroid cancer |
| Control subjects | – | –Subjects with non-cancerous thyroid pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with thyroid carcinoma originating from the follicular thyroid cell at varying degrees of malignancy. For such a retrospective population, considering the study's primary objective of identifying potential tissue biomarkers of pathology, an a posteriori power analysis was performed, considering a paired statistical design of the case-control type, where the control group is afferent to the healthy counterpart of the tissues available in the archives of the same thyroid carcinoma patients. For the subgroup analyses associated with the different degrees of invasiveness/aggressiveness, the statistical power associated with the possible clinical stratifications will be assessed before proceeding with the statistical analyses
Key inclusion criteria (1 listed)
- Patients of either sex aged > 18 years with thyroid cancer of follicular origin.
Key exclusion criteria (1 listed)
- Patients who do not fit the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of novel molecular biomarkers associated with the progression and aggressiveness of follicular-derived thyroid carcinomas
Time frame: 1-36 months
RNA-seq and miRNA-seq on serum samples
Determine genetic alterations hat may contribute to disease progression
Time frame: 1-36 months
Identification of mutations, copy number variations, and tumor mutation burden)
1 secondary outcome
Develop of predictive models for improved risk stratification and prognosis
Time frame: 12-36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Background: PubMed 35634500Rossi ED, Locantore P, Bruno C, Dell'Aquila M, Tralongo P, Curatolo M, Revelli L, Raffaelli M, Larocca LM, Pantanowitz L, Pontecorvi A. Molecular Characterization of Thyroid Follicular Lesions in the Era of "Next-Generation" Techniques. Front Endocrinol (Lausanne). 2022 May 12;13:834456. doi: 10.3389/fendo.2022.834456. eCollection 2022.
- Background: PubMed 32284020Xu B, Fuchs T, Dogan S, Landa I, Katabi N, Fagin JA, Tuttle RM, Sherman E, Gill AJ, Ghossein R. Dissecting Anaplastic Thyroid Carcinoma: A Comprehensive Clinical, Histologic, Immunophenotypic, and Molecular Study of 360 Cases. Thyroid. 2020 Oct;30(10):1505-1517. doi: 10.1089/thy.2020.0086. Epub 2020 May 8.
- Background: PubMed 33799953Macerola E, Poma AM, Vignali P, Basolo A, Ugolini C, Torregrossa L, Santini F, Basolo F. Molecular Genetics of Follicular-Derived Thyroid Cancer. Cancers (Basel). 2021 Mar 7;13(5):1139. doi: 10.3390/cancers13051139.
- Background: PubMed 35020204Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
- Individual participant dataSharing planned: No
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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.
Laura Pierri contact
Giovanni Smaldone principal investigator
IRCCS SYNLAB SDN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by IRCCS SYNLAB SDN at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Smaldone, Master degree in biothecnology (+39 0812408294, giovanni.smaldone@synlab.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of novel molecular biomarkers associated with the progression and aggressiveness of follicular-derived thyroid carcinomas (time frame: 1-36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878534, which also lists 5 linked publications.
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 17 Mar 2025.