Evaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas

NCT06863805 | Recruiting

• 2 other identifiers: BIOTYRRC-2022-2773340
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aimed at all adult patients diagnosed with advanced thyroid carcinomas and well-differentiated thyroid carcinomas (DTC) iodine-refractory, well-differentiated iodine-refractory thyroid (RAI-R DTC) metastatic carcinomas that are candidates for systemic therapy. By simple blood sampling and analysis on peripheral blood of circulating DNA (ccf-DNA), circulating RNA (ccf-RNA), and counting and analysis of circulating tumor cells through the use of liquid biopsy, molecular profiling corresponding to those obtained by genomic sequencing on tumor tissue can be arrived at, depending on optimal therapeutic choices

Conditions

Thyroid Carcinoma

Keywords

carcinomas of thyroid; molecular markers; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• Genomic alterations

  Presence of BRAF mutations, RAS mutations, RET mutations, rearrangements of NTRK, RET, ALK, etc. in ccf-DNA, ccf-RNA and Circulating Tumour Cells (CTCs)

  Before the start of pharmacologic treatment and after 30 days and 3, 6 and 24 months after the start of treatment

Secondary Outcomes (6)

• Early metabolic response rate

  30 days from the start of pharmacologic treatment

• Overall response rate (ORR)

  Throughout the study duration, an average of 24 months

• Progression-free survival (PFS)

  Throughout the study duration, an average of 24 months

• Tumour load

  Throughout the study duration, an average of 24 months

• Number of Circulatin Tumour cells (CTC) (CTC/ml)

  Before the start of pharmacologic treatment and after 30 days and 3, 6 and 24 months after the start of treatment

Study Arms (1)

Patients with advanced thyroid carcinomas

Adults patients with advanced thyroid carcinomas will be enrolled.

Diagnostic Test: 4 EDTA tubes of peripheral blood for Multigene analysis on ccf-DNA and ccf-RNA

Interventions

4 EDTA tubes of peripheral blood for Multigene analysis on ccf-DNA and ccf-RNA DIAGNOSTIC_TEST

For each patient enrolled in the present study, 4 EDTA tubes of peripheral blood will be collected to be used to obtain molecular profiling during scheduled laboratory controls as per normal clinical practice according to the following time schedule: * T0 = basal collection before initiation of systemic treatment; * T1 = sampling at 1 month after the start of systemic treatment; * T2 = sampling at 3 months (+/- 1 month) after the start of systemic treatment at the first instrumental re-evaluation of disease; * T3 = sampling at 6 months (+/- 1 month) from the start of systemic treatment at the time of instrumental disease reassessment; * T4 = sampling at the time of evidence of instrumental disease progression within 24 months of treatment initiation. The following analyses will be conducted on the samples thus collected: * multigenic analysis on ccf-DNA and ccf-RNA at baseline, i.e., before the initiation of systemic treatment; * isolation, counting and analysis of CTCs at baseline vi

Patients with advanced thyroid carcinomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients (≥ 18 years) with metastatic RAI-R DTC who are candidates for systemic therapy, as per clinical practice

You may qualify if:

• Signed written informed consent,
• Adult (≥18 years) male or female patients
• Histologic diagnosis of advanced thyroid carcinoma confirmed at centralized review,
• well-differentiated thyroid carcinomas, medullary thyroid carcinomas, anaplastic thyroid carcinomas, advanced, candidates for initiation of systemic medical therapy,
• Availability of biomolecular profiling performed by multigenic NGS panel on tumor tissue,
• Measurable disease by conventional imaging adopted in clinical practice (total body CT with mdc, CT-PET with FDG or F-DOPA).

You may not qualify if:

• Patients already receiving previous lines of systemic therapy,
• Patients not eligible for systemic therapy.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero universitaria Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Manuela Ianni

  Ospedale S. Orsola-Malpighi

  STUDY CHAIR

Central Study Contacts

Margherita Nannini

CONTACT

+390512142207; margherita.nannini@unibo.it

Maria Abbondanza Pantaleo

CONTACT

+390512142208; maria.pantaleo@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 7, 2025
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)