NCT05789680

European Multicentric Study on Parathyroid Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 17 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Parathyroid Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2023-03-29
• Last updated: 2023-03-29

Locations

1 site across 1 country: Italy