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NCT05766098 Clinical Trial

Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY

Papillary Thyroid Cancer Clinical Trial

— PTC-ARRAY  

Official title:
Caratterizzazione Del Profilo Mutazionale Nel Tumore Papillare Della Tiroide Tramite Tecnologia Mass-ARRAY

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05766098
Other study ID # 05C825
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2019
Est. completion date December 31, 2027

Study information
Verified date March 2023
Source Istituto Auxologico Italiano
Contact Marina Muzza, PhD
Phone +390261191
Email m.muzza@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Somatic mutations in the MAP (mitogen-activated protein) kinase pathway have been found in about 80% of papillary thyroid tumors (PTCs). The evaluation of the PTC mutational profile is crucial for the definition of the prognosis and for predicting the effects of targeted and personalized therapies. Molecular characterization by mass spectrometry (Mass ARRAY) allows the search for multiple mutations in a single experiment, in a sensitive, fast and economic way. A Mass ARRAY platform (PTC-MA) was developed, capable of identifying the presence of the most common somatic point mutations and rearrangements in PTC (Pesenti et al., Endocrine 2017). The aim of the study is to characterize the mutational profile of a large series of papillary thyroid carcinomas (PTC). Tumor samples will be analyzed using our PTC-MA platform. The molecular profile of PTCs will be correlated with the clinical and prognostic characteristics of the patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2027
Est. primary completion date October 30, 2027
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with papillary thyroid cancer - patients whose tumor tissue can be recovered for genetic analysis Exclusion Criteria: - patients who did not give consent - patients lost to follow-up - tumor samples not suitable for genetic analysis

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Genotyping
Characterization of genetic profile of tumor tissues

Locations
Country Name City State
Italy Istituto Auxologico Italiano Milan MI

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pesenti C, Muzza M, Colombo C, Proverbio MC, Fare C, Ferrero S, Miozzo M, Fugazzola L, Tabano S. MassARRAY-based simultaneous detection of hotspot somatic mutations and recurrent fusion genes in papillary thyroid carcinoma: the PTC-MA assay. Endocrine. 20 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mutational profile of PTCs The mutational profile of about 600 PTCs will be characterized and correlate with the clinical characteristics and patient outcomes years 1-8
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