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RecruitingNCT05766098PTC-ARRAYUpdated Oct 8, 2024

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

An observational study in Papillary Thyroid Cancer, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
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Study 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.

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Conditions studied

  • Papillary Thyroid Cancer
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In context

Thyroid Cancer, Papillary

178 studies on the registry are indexed under Thyroid Cancer, Papillary; 54 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 67 observational studies indexed under Thyroid Cancer, Papillary.

Browse Thyroid Cancer, Papillary studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with papillary thyroid cancer

    Genetic: Genotyping

Interventions

  • GeneticGenotyping

    Characterization of genetic profile of tumor tissues

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What researchers measure

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

    Time frame: years 1-8

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 29214440 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05766098
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Jan 8, 2019
Primary completion
Oct 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 8, 2024

Study contacts

Marina Muzza, PhD
Contact
m.muzza@auxologico.it
+390261191 ext. 2432
Laura Fugazzola, MD PhD
principal investigator · Istituto Auxologico Italiano-Milan, Italy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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