Institution of an Italian Multicenter Database of Patients with Parathyroid Carcinoma or Atypical Parathyroid Adenoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorF.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore

About this trial

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:

1. 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. 2. 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. 3. 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. 4. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort 1: parathyroid carcinoma

Cohort 2: atypical parathyroid adenoma

Disqualifiers

None

Trial population

Male and female patients of any age who developed parathyroid carcinoma (cohort 1) or atypical parathyroid adenoma (cohort 2), both as sporadic disease or in the context of a genetic disorder

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Patients with parathyroid carcinoma
Group B: Patients with atypical parathyroid adenoma

Trial outcomes

Primary outcomes

1

Prevalence and incidence evaluation

Evaluation of prevalence and incidence of parathyroid carcinoma and of atypical parathyroid adenoma in Italy

Time frame
Through study completion, an average of 10 years
2

Comparative characterization of parathyroid carcinoma and atypical parathyroid

Comparative analysis of clinical, histological, and biochemical features in parathyroid carcinoma vs atypical parathyroid adenoma

Time frame
Through study completion, an average of 10 years
3

Therapy response in parathyroid carcinoma and atypical parathyroid

Analysis of short-term and long-term responses to treatments (surgery and/or pharmacological therapies) in parathyroid carcinoma and atypical parathyroid adenoma

Time frame
Through study completion, an average of 10 years
4

Therapy response in sporadic and genetic forms of disease

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

Time frame
Through study completion, an average of 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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