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

NCT ID: NCT05766098

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-08

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Papillary Thyroid Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with papillary thyroid cancer

Genotyping

Intervention Type GENETIC

Characterization of genetic profile of tumor tissues

Interventions

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Genotyping

Characterization of genetic profile of tumor tissues

Intervention Type GENETIC

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Fugazzola, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano-Milan, Italy

Locations

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Istituto Auxologico Italiano

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marina Muzza, PhD

Role: CONTACT

+390261191 ext. 2432

Facility Contacts

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Gianfranco Parati, MD

Role: primary

0261911 ext. 2890

References

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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.

Reference Type RESULT
PMID: 29214440 (View on PubMed)

Other Identifiers

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05C825

Identifier Type: -

Identifier Source: org_study_id

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