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

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766098

Collaborator

(none)

600

Enrollment

Location

107.7

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papillary Thyroid Cancer	Genetic: Genotyping

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 8, 2019

Anticipated Primary Completion Date :

Oct 30, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Patients with papillary thyroid cancer	Genetic: Genotyping Characterization of genetic profile of tumor tissues

Arm

Intervention/Treatment

Patients with papillary thyroid cancer

Genetic: Genotyping

Characterization of genetic profile of tumor tissues

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano	Milan	MI	Italy	20145

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

Principal Investigator: Laura Fugazzola, MD PhD, Istituto Auxologico Italiano-Milan, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05766098

Other Study ID Numbers:

05C825

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Cancer, Papillary

Thyroid Diseases

Study Results

No Results Posted as of Mar 13, 2023