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

NCT05766098 | Recruiting

• 1 other identifier: 05C825
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with papillary thyroid cancer

Genetic: Genotyping

Interventions

Genotyping GENETIC

Characterization of genetic profile of tumor tissues

Patients with papillary thyroid cancer

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with papillary thyroid cancer, operated and followed by our Center of Excellence for the Diagnosis and Treatment of Thyroid Tumors

You may qualify if:

• patients with papillary thyroid cancer
• patients whose tumor tissue can be recovered for genetic analysis

You may not qualify if:

• patients who did not give consent
• patients lost to follow-up
• tumor samples not suitable for genetic analysis

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, MI, 20145, Italy

RECRUITING

Related 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. 2018 Jul;61(1):36-41. doi: 10.1007/s12020-017-1483-2. Epub 2017 Dec 6.

  PMID: 29214440 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

papillary thyroid tumor tissue

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Genotype

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Laura Fugazzola, MD PhD

  Istituto Auxologico Italiano-Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Muzza, PhD

CONTACT

+390261191; m.muzza@auxologico.it

Study Design

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

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 13, 2023
• Study Start: January 8, 2019
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

IT (1)