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Trial Title:
European Multicentric Study on Parathyroid Carcinoma
NCT ID:
NCT05789680
Condition:
Parathyroid Carcinoma
Conditions: Official terms:
Carcinoma
Parathyroid Neoplasms
Parathyroid Hormone
Conditions: Keywords:
parathyroid carcinoma
primary hyperparathyroidism
Eurocrine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Surgical treatment of parathyroid carcinoma
Description:
Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy
and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.
Arm group label:
Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism
Other name:
parathyroidectomy
Other name:
ipsilateral hemithyroidectomy
Other name:
ipsilateral central neck dissection
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.
Criteria for eligibility:
Study pop:
Patients with final histology of parathyroid carcinoma operated among European centers
that participate in the Eurocrine® database between 2015 and 2021
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Pennestrì, Dr
Phone:
3280244528
Email:
francesco.pennestri@policlinicogemelli.it
Start date:
December 15, 2022
Completion date:
September 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789680
