Creation, Management and Analysis of a National Database of Patients with Parathyroid Carcinoma or Atypical Parathyroid Adenoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- Prevalence and incidence evaluation
研究概览
简要总结
The goal of this observational study is to create, manage and analyze a multicenter national database of patients with parathyroid carcinoma or atypical parathyroid adenoma, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, histological, and therapeutic data in a relatively wide number of patients in Italy.
The study will include 33 specialist clinical centers of endocrinology and endocrine surgery, located throughout the Italian territory, and to which patients refer from all the 20 regions of Italy.
Data will be collected over time, both in retrospective and prospective manners, during the 10-year duration of the study, starting from the recruiting visit (basal visit) and then during each follow-up visits patients will undergo for the control of disease progression at the recruiting clinical centers.
Collected data will include both the most classic traits of the pathology and the less common ones, with the final goal of refining and deepening medical knowledge in the field of these two extremely rare parathyroid cancers and be able to define optimal clinical and therapeutic management of patients, improving their quality and life expectancy.
The main aspects this observational study aims to assess and clarify are:
- Evaluation of prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy, both as sporadic disease or in the context of genetic disorders.
- Clinical, histological, and biochemical characterization of parathyroid carcinoma vs atypical parathyroid adenoma, to assess features and aspects that distinguish these two kinds of tumors and may help in the differential diagnosis.
- Evaluation of short-term and long-term response to therapies in patients with parathyroid carcinoma and in patients with atypical parathyroid adenoma to assess possible differences between these two types of cancer and, thus, to design tailored clinical and therapeutic managements for patients.
- Evaluation of short-term and long-term response to therapies in sporadic forms vs genetic forms of parathyroid carcinoma and atypical parathyroid adenoma, to assess possible differences between these two different forms of diseases and, thus, to design tailored clinical and therapeutic managements for patients.
The study will include two independent cohorts of female and male patients of any age, one including patients who developed parathyroid carcinoma (cohort 1) and one including patients who developed atypical parathyroid adenoma (cohort 2), both as sporadic cancer or in the context of genetic diseases. The study does not include either any control group/comparison group or healthy volunteers.
The study itself does not involve any medical intervention or drug administration. Treatments (surgery and/or drugs), for which data on response to therapy will be collected in the database, are those that are conventionally used in patients with parathyroid carcinoma or atypical parathyroid adenoma for treatment of their pathology, regardless of their inclusion in this observational study.
详细描述
A. Background and rationale:
Parathyroid carcinoma (PC) and atypical parathyroid adenoma (aPA) are two extremely rare forms of cancer of the parathyroid glands, that represent approximately 1% of all parathyroid tumors.
The extreme rarity of these two types of tumor results in a lack of specific and detailed clinical information on them. This, together with the current scarcity and incompleteness of multicenter and prospective studies on large case series, has not yet allowed to reach a shared consensus for the clinical and therapeutic management and follow-up of these tumors, nor the creation of specific guidelines. For this reason, the institution and management of national multicenter databases of patients with parathyroid carcinoma or atypical parathyroid adenoma are extremely important to allow the collection of a relatively high number of patients with these two endocrine cancers, whose clinical features could be, then, carefully studied in every aspect of the disease, from the most classic traits of the pathology to the less common ones, in both retrospective and prospective manners.
B. Main aim and specific objectives:
Main goal of this observational study is to create, manage and analyze a retro-prospective multicenter national database of patients with parathyroid carcinoma or atypical parathyroid adenoma in Italy, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, histological, and therapeutic data on these two extremely rare parathyroid cancers in a relatively wide number of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1: parathyroid carcinoma
- •Cohort 2: atypical parathyroid adenoma
排除标准
- 未提供
结局指标
主要结局
Prevalence and incidence evaluation
时间窗: Through study completion, an average of 10 years
Evaluation of prevalence and incidence of parathyroid carcinoma and of atypical parathyroid adenoma in Italy
Comparative characterization of parathyroid carcinoma and atypical parathyroid
时间窗: Through study completion, an average of 10 years
Comparative analysis of clinical, histological, and biochemical features in parathyroid carcinoma vs atypical parathyroid adenoma
Therapy response in parathyroid carcinoma and atypical parathyroid
时间窗: Through study completion, an average of 10 years
Analysis of short-term and long-term responses to treatments (surgery and/or pharmacological therapies) in parathyroid carcinoma and atypical parathyroid adenoma
Therapy response in sporadic and genetic forms of disease
时间窗: Through study completion, an average of 10 years
Analysis of short-term and long-term responses to treatments (surgery and/or pharmacological therapies) in sporadic vs genetic forms of parathyroid carcinoma and atypical parathyroid adenoma
次要结局
未报告次要终点