Papillary Thyroid Cancer Clinical Trial
— PTC-ARRAYOfficial title:
Caratterizzazione Del Profilo Mutazionale Nel Tumore Papillare Della Tiroide Tramite Tecnologia Mass-ARRAY
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto Auxologico Italiano | Milan | MI |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Auxologico Italiano |
Italy,
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
| 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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