European Multicentric Study on Parathyroid Carcinoma

NCT ID: NCT05789680

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parathyroid Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Surgical treatment of parathyroid carcinoma

Intervention Type PROCEDURE

Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

parathyroidectomy ipsilateral hemithyroidectomy ipsilateral central neck dissection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marco Raffaelli, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Francesco Pennestrì, Dr

Role: CONTACT

3280244528 ext. +39

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Francesco Pennestrì, Dr

Role: primary

3280244528

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5287

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.