Parathyroid CarcinomaEMS-PCNCT05789680
European Multicentric Study on Parathyroid Carcinoma
An observational study of Parathyroid Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Carcinoma
- What is being tested?
- Surgical treatment of parathyroid carcinoma
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2022to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with final histology of parathyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021
Who may be able to join
- All adult (18 years old and older) patients
- underwent surgery
- final histology of parathyroid carcinoma
- among European centers that participate in the Eurocrine® database between 2015 and 2021
Who cannot join
- Patients <18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Francesco Pennestrì, Dr, 3280244528, francesco.pennestri@policlinicogemelli.it
About this study
The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category.
Read the detailed description
Parathyroid cancer (PC) is one of the rarest malignancies (0.005% of all tumours) and it represents less than 1% of all the causes of primary hyperparathyroidism (pHPT).
It is frequently a sporadic disease, but it can be part of hereditary syndromes (i.e. HPT- JT, MEN, MEN2A and FIHP).
Clinical and biochemical presentation is usually more severe comparing to other forms of primary hyperparathyroidism as it is often associated to very high serum-calcium and PTH levels and target organs' damages.
Malignancy should be suspected on the basis of the aforementioned biochemical data and the imaging evidences (such as parathyroid lesion dimension >3 cm, faded edges, inhomogeneous internal features and cervical lymph nodes enlargement).
In case of suspected PC a radical treatment should be proposed to the patient, consisting of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and ipsilateral central neck dissection. Indeed, the oncological radicality during surgical treatment is mandatory, as effective adjuvant therapy is not available.
However, pre-operative differential diagnosis with parathyroid adenoma is still challenging, thus malignancy can be detected only after the histological analysis of the specimen and sometimes after recurrences.
Moreover, parathyroid atypical adenoma entity is still controversial, as it presents suspicious histological features, but certain signs of malignancy are lacking (such as capsular, vessels and neural invasion). Furthermore, natural history and biological behaviour are still unknown.
- Conditions
- Parathyroid Carcinoma
- Being tested
- Surgical treatment of parathyroid carcinoma
- Keywords
- parathyroid carcinoma, primary hyperparathyroidism, Eurocrine
- Medical subject headings
- Parathyroid Neoplasms, Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of parathyroid carcinomaProcedure or surgery
Also called parathyroidectomy, ipsilateral hemithyroidectomy, ipsilateral central neck dissection
Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism | All adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for primary hyperparathyroidism and received histopathologic diagnosis of parathyroid carcinoma from 2015 till 2021 will be included Receives: Procedure: Surgical treatment of parathyroid carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of parathyroid carcinoma
Descriptive analysis of the exact incidence of parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism in European centers.
Measured: January 2015-January 2021
Secondary outcomes (1)
Oncologic outcome
Descriptive analysis of operative and oncologic outcome of patients undergoing surgical treatment of primary hyperparathyroidism and receiving pathological report od parathyroid carcinoma in European centers.
Measured: January 2015-January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start15 Dec 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Retrospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Raffaelli, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789680
- Sponsor's protocol ID
- 5287
- Acronym
- EMS-PC
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests will be evaluated by the Eurocrine Council
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicentric Study on Parathyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05789680
- Acronym / sponsor ID
- EMS-PC / 5287
- Conditions
- Parathyroid Carcinoma
- Keywords
- parathyroid carcinoma, primary hyperparathyroidism, Eurocrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 29 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.
The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category.
Detailed description
Parathyroid cancer (PC) is one of the rarest malignancies (0.005% of all tumours) and it represents less than 1% of all the causes of primary hyperparathyroidism (pHPT).
It is frequently a sporadic disease, but it can be part of hereditary syndromes (i.e. HPT- JT, MEN, MEN2A and FIHP).
Clinical and biochemical presentation is usually more severe comparing to other forms of primary hyperparathyroidism as it is often associated to very high serum-calcium and PTH levels and target organs' damages.
Malignancy should be suspected on the basis of the aforementioned biochemical data and the imaging evidences (such as parathyroid lesion dimension >3 cm, faded edges, inhomogeneous internal features and cervical lymph nodes enlargement).
In case of suspected PC a radical treatment should be proposed to the patient, consisting of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and ipsilateral central neck dissection. Indeed, the oncological radicality during surgical treatment is mandatory, as effective adjuvant therapy is not available.
However, pre-operative differential diagnosis with parathyroid adenoma is still challenging, thus malignancy can be detected only after the histological analysis of the specimen and sometimes after recurrences.
Moreover, parathyroid atypical adenoma entity is still controversial, as it presents suspicious histological features, but certain signs of malignancy are lacking (such as capsular, vessels and neural invasion). Furthermore, natural history and biological behaviour are still unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism | – | Procedure: Surgical treatment of parathyroid carcinomaAll adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for primary hyperparathyroidism and received histopathologic diagnosis of parathyroid carcinoma from 2015 till 2021 will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with final histology of parathyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021
Key inclusion criteria (4 listed)
- All adult (18 years old and older) patients
- underwent surgery
- final histology of parathyroid carcinoma
- among European centers that participate in the Eurocrine® database between 2015 and 2021
Key exclusion criteria (1 listed)
- Patients <18 years old
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 |
|---|---|---|
| Surgical treatment of parathyroid carcinomaAlso: parathyroidectomy, ipsilateral hemithyroidectomy, ipsilateral central neck dissectionRadical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection. | Procedure or surgery | Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism |
Primary outcome
Incidence of parathyroid carcinoma
Time frame: January 2015-January 2021
Descriptive analysis of the exact incidence of parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism in European centers.
1 secondary outcome
Oncologic outcome
Time frame: January 2015-January 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided. Reasonable requests will be evaluated by the Eurocrine Council
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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. This study is not recruiting at the moment.
Marco Raffaelli, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Parathyroid Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pennestrì, Dr (3280244528 ext. +39, francesco.pennestri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of parathyroid carcinoma (time frame: January 2015-January 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.