Papillary Thyroid CancerPTC-ARRAYNCT05766098
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
An observational study of Papillary Thyroid Cancer, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- Genotyping
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients diagnosed with papillary thyroid cancer, operated and followed by our Center of Excellence for the Diagnosis and Treatment of Thyroid Tumors
Who may be able to join
- patients with papillary thyroid cancer
- patients whose tumor tissue can be recovered for genetic analysis
Who cannot join
- patients who did not give consent
- patients lost to follow-up
- tumor samples not suitable for genetic analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, MI, 20145
Gianfranco Parati, MD, 0261911 ext. 2890, gianfranco.parati@unimib.it
About this study
Official title: Caratterizzazione Del Profilo Mutazionale Nel Tumore Papillare Della Tiroide Tramite Tecnologia Mass-ARRAY
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
- Being tested
- Genotyping
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingGenetic
Characterization of genetic profile of tumor tissues
| Study group | Role | What they receive |
|---|---|---|
| Patients with papillary thyroid cancer | Not described Receives: Genetic: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutational profile of PTCs
The mutational profile of about 600 PTCs will be characterized and correlate with the clinical characteristics and patient outcomes
Measured: years 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start8 Jan 2019
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Fugazzola, MD PhD, Principal investigator, Istituto Auxologico Italiano-Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766098
- Sponsor's protocol ID
- 05C825
- Acronym
- PTC-ARRAY
- Status last verified
- Nov 2026
- First submitted
- 28 Feb 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caratterizzazione Del Profilo Mutazionale Nel Tumore Papillare Della Tiroide Tramite Tecnologia Mass-ARRAY
- ClinicalTrials.gov ID
- NCT05766098
- Acronym / sponsor ID
- PTC-ARRAY / 05C825
- Conditions
- Papillary Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with papillary thyroid cancer | – | Genetic: Genotyping |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with papillary thyroid cancer, operated and followed by our Center of Excellence for the Diagnosis and Treatment of Thyroid Tumors
Key inclusion criteria (2 listed)
- patients with papillary thyroid cancer
- patients whose tumor tissue can be recovered for genetic analysis
Key exclusion criteria (3 listed)
- patients who did not give consent
- patients lost to follow-up
- tumor samples not suitable for genetic analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingCharacterization of genetic profile of tumor tissues | Genetic | Patients with papillary thyroid cancer |
Primary outcome
Mutational profile of PTCs
Time frame: years 1-8
The mutational profile of about 600 PTCs will be characterized and correlate with the clinical characteristics and patient outcomes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 29214440Pesenti 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.
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Studies on Tumors of the Thyroid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Fugazzola, MD PhD principal investigator
Istituto Auxologico Italiano-Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Cancer, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Muzza, PhD (+390261191 ext. 2432, m.muzza@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutational profile of PTCs (time frame: years 1-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.