An observational study in Thyroid Cancer, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by IRCCS SYNLAB SDN · Observational
Among 58 studies in Thyroid Neoplasms with a site in Italy — 18 open to participants now, 22 under way, 1 of them phase 3. Thyroid Neoplasms · Italy.
Among the 58 studies in Thyroid Neoplasms with a site in Italy, this one is the 18th largest by planned enrollment of the 27 observational ones that give a count, is one of 7 that started in 2023, is one of 27 observational ones, reaches primary completion later than 4 of the 21 other live ones, and was the 53rd registered.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
Browse Thyroid Neoplasms studies →18 of the 58 studies in Thyroid Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
Università Cattolica di Milano · Sites in Italy
Ages 18–100
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 10–43
Azienda Ospedaliera di Padova · Sites in Italy
Ages 0–18
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
University of Cagliari · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 17 · Phase 3 8 · Phase 4 2
First in 2004; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is below the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Median enrollment 200 across the 31 interventional studies, 144 across the 27 observational. Of the 31 that completed or were terminated, 15 (48%) have results posted.
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23 of 58 have an industry lead sponsor. The 10 most frequent:
IRCCS SYNLAB SDN is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
IRCCS SYNLAB SDN has 1 study filed under Thyroid Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Thyroid Neoplasms with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05852223Istituti Clinici Scientifici Maugeri SpAPembrolizumab in High-risk Thyroid Cancer | 2026-11 |
| NCT06863805IRCCS Azienda Ospedaliero-Universitaria di BolognaEvaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas | 2026-12-31 |
| NCT05428371University of CagliariAssessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features | 2027-05-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 58 studies in Thyroid Neoplasms with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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
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Exclusion Criteria:
Patients with thyroid cancer
Subjects with non-cancerous thyroid pathology
Identification of novel molecular biomarkers associated with the progression and aggressiveness of follicular-derived thyroid carcinomas
RNA-seq and miRNA-seq on serum samples
Time frame: 1-36 months
Determine genetic alterations hat may contribute to disease progression
Identification of mutations, copy number variations, and tumor mutation burden)
Time frame: 1-36 months
Develop of predictive models for improved risk stratification and prognosis
Application of machine learning approach to integrate transcriptomic and genomic data
Time frame: 12-36 months
Plan to share: No
Ran from Mar 2023 to primary completion in Jul 2024, 16 months.
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IRCCS SYNLAB SDN