European Multicentric Study on Parathyroid Carcinoma (EMS-PC)

March 16, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with final histology of parathyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021

Description

Inclusion Criteria: All adult (18 years old and older) patients that underwent surgery for primary hyperparathyroidism with a final histology of parathyroid carcinoma from 2015 till 2021.

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Patients <18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Surgical treatment of parathyroid carcinoma
Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.
Other Names:
  • parathyroidectomy
  • ipsilateral hemithyroidectomy
  • ipsilateral central neck dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 2015-January 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic outcome
Time Frame: January 2015-January 2021
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.
January 2015-January 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Marco Raffaelli, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Reasonable requests will be evaluated by the Eurocrine Council

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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