Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05789680 |
| Other study ID # |
5287 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
September 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Francesco Pennestrì, Dr |
| Phone |
3280244528 |
| Email |
francesco.pennestri[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. Moreover, we aim to evaluate the
peri-operative surgical characteristics, operation extent, postoperative morbidity, and
outcomes in these patients category.
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.
