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临床试验/NCT05789680
NCT05789680招募中不适用

European Multicentric Study on Parathyroid Carcinoma

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
17
试验地点
1
主要终点
Incidence of parathyroid carcinoma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult (18 years old and older) patients that underwent surgery for primary hyperparathyroidism with a final histology of parathyroid carcinoma from 2015 till
  • 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

排除标准

  • Patients <18 years old

结局指标

主要结局

Incidence of parathyroid carcinoma

时间窗: January 2015-January 2021

Descriptive analysis of the exact incidence of parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism in European centers.

次要结局

  • Oncologic outcome(January 2015-January 2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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