Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789680
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-03-16
Brief Title:
European Multicentric Study on Parathyroid Carcinoma
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
European Multicentric Study on Parathyroid Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMS-PC
Brief 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 0005 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 ie 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
It is frequently a sporadic disease but it can be part of hereditary syndromes ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None