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

Recruiting

• Conditions: Papillary Thyroid Cancer
• Interventions: Genetic: Genotyping

• Registration Number: NCT05766098
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2027-10-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with papillary thyroid cancer	Genotyping	-

Primary Outcome Measures

Name	Time	Method
Mutational profile of PTCs	years 1-8	The mutational profile of about 600 PTCs will be characterized and correlate with the clinical characteristics and patient outcomes

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milan, MI, Italy