Actively Recruiting
Evaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-03-07
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on adults diagnosed with advanced thyroid carcinomas, including well-differentiated iodine-refractory metastatic thyroid carcinomas, who are candidates for systemic therapy. The study evaluates the use of liquid biopsy, a noninvasive blood test analyzing circulating free DNA (ccf-DNA), circulating free RNA (ccf-RNA), and circulating tumor cells (CTCs), to obtain molecular profiles similar to those from tumor tissue genomic sequencing. This approach aims to improve therapeutic choices for patients with advanced thyroid cancer. Participants will have blood samples collected at multiple points: before starting systemic treatment, and at 1 month, 3 months, 6 months, and upon disease progression within 24 months after treatment initiation. These samples will undergo multigenic analysis of ccf-DNA and ccf-RNA, along with counting and analysis of CTCs. The study compares these liquid biopsy results with existing tumor tissue profiles to identify gene alterations and explore markers predicting treatment response and disease evolution. During the study, participants will undergo scheduled blood collections alongside routine laboratory visits. Researchers will measure gene alterations, metabolic response by FDG CT-PET, overall response rate, progression-free survival, tumor burden, and circulating tumor cell count and phenotype. The study is observational and aims to monitor these outcomes over about 24 months to assess the clinical utility of circulating biomarkers in guiding systemic therapy for advanced thyroid carcinomas.
CONDITIONS
Brief Title
Evaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Adult (≥18 years) male or female patients
- Histologic diagnosis of advanced thyroid carcinoma confirmed at centralized review
- Includes well-differentiated, medullary, and anaplastic thyroid carcinomas, advanced and candidates for systemic medical therapy
- Availability of biomolecular profiling by multigenic NGS panel on tumor tissue
- Measurable disease by conventional imaging such as total body CT with contrast, CT-PET with FDG or F-DOPA
You will not qualify if you...
- Patients who have received previous lines of systemic therapy
- Patients not eligible for systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo scheduled blood sampling to collect circulating biomarkers for molecular profiling before and during systemic treatment.
5 visits at baseline, 1 month, 3 months, 6 months, and at disease progression
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero universitaria Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
M
Margherita Nannini
M
Maria Abbondanza Pantaleo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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