Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Institution of an Italian Multicenter Database of Patients With Parathyroid Carcinoma or Atypical Parathyroid Adenoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Creation Management and Analysis of a National Database of Patients With Parathyroid Carcinoma or Atypical Parathyroid Adenoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 groupcomparison group or healthy volunteers
The study itself does not involve any medical intervention or drug administration Treatments surgery andor 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
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 groupcomparison group or healthy volunteers
The study itself does not involve any medical intervention or drug administration Treatments surgery andor 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
Detailed Description:
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
Such a database will allow for an epidemiological evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy and to collect case history of patients whose clinical cases will be studied in detail and followed over time up to 10 years after the recruitment in the study also as post-operative follow-up in order to refine knowledge in the field of these two rare and malignant parathyroid tumors to identify the most effective therapy and direct future research in the identification of possible specific therapeutic targets
Specific objectives of the studies are
1 Creation of an Italian centralized multicenter database of patients with parathyroid carcinoma or atypical parathyroid adenoma through the collection of patients at 33 specialist clinical centers of endocrinology and endocrine surgery located throughout the Italian territory and visiting patients from all the 20 regions of Italy
2 Collection of a relatively high number of patients with parathyroid carcinoma or atypical parathyroid adenoma both as sporadic tumors or in the context of genetic disorders
3 Retrospective collection of data about past clinical history of parathyroid carcinoma and atypical parathyroid adenoma at the time of the recruiting visit
4 Continuous and updated prospective collection of patients data over time starting from the first recruiting visit up to 10 years after the recruitment in the study
5 Evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy both as sporadic disease or in the context of genetic disorders
6 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
7 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
8 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
C Study population
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 groupcomparison group or healthy volunteers
Given the extreme rarity of parathyroid carcinoma and atypical parathyroid adenoma we estimate that we will be able to include in the study a minimum of 100 and a maximum of 300 patients affected by parathyroid carcinoma or atypical parathyroid adenoma during the 10 years of the study
Inclusion criteria
Cohort 1 parathyroid carcinoma
Cohort 2 atypical parathyroid adenoma Exclusion criteria
None
D Study design and setting
Non-profit multicenter national retro-prospective observational study consisting in the design creation management and analysis of an Italian database of patients with parathyroid carcinoma or atypical parathyroid adenoma
The study will last 10 years The enrollment of patients with parathyroid carcinoma or atypical parathyroid adenoma the inclusion in the database with retrospective collection of their clinical data and the subsequent prospective collection of clinical follow-up data will take place throughout the duration of the study For the retrospective collection retrospective data on parathyroid carcinoma or atypical parathyroid adenoma will be retrieved from patients medical records at the time of the medical visit that the patient will carry out at the Clinical Center for the evaluation of hisher parathyroid disease regardless of inclusion in this study Prospective data relating to the tumor follow-up will be collected during the subsequent medical follow-up visits scheduled for each patient as part of the clinical management of hisher parathyroid disease regardless of inclusion in this study
Being an observational study this study itself does not involve the administration of any drug nor the use of any medical device nor does it involve additional medical visits clinical analyses or care procedures in addition to those conventionally scheduled for the clinical and therapeutic management of patient affected by parathyroid carcinoma or atypical parathyroid adenoma No participant biospecimens of any type will be collected and retained to perform this study Pharmacological treatments and parathyroid surgery for which data on response to therapy and peri-operative and post-operative outcomes will be collected in the database during the study are those that are conventionally administered and performed in patients with parathyroid carcinoma or atypical parathyroid adenoma in the context of treatment of their pathology regardless of their inclusion in this observational study
All data will be collected anonymously and they will be analyzed as aggregates Data collected in the database will be first processed using descriptive statistics such as frequency tables for categorical data median and quartiles for quantitative data on ordinal scales and mean and standard deviation for quantitative data on metric scales Secondly the correlations between variables will be evaluated using the Pearson correlation index in the case of continuous variables and the chi-square test for categorical variables
E Data and variables
Data collected in the database will include if available in patients medical records
Demographics sex year of birth
Family history of parathyroid carcinomaatypical parathyroid adenoma or other parathyroid diseases in first-degree relatives
Lifestyle habits ie smoke alcohol intake
History of neck irradiation
Clinical history and therapy of hyperparathyroidism prior to diagnosis of parathyroid carcinomaatypical parathyroid adenoma
Presence of comorbidities
Age at diagnosis of parathyroid carcinomaatypical parathyroid adenoma type of diagnosis genetic test if performed
Clinical manifestations of parathyroid carcinomaatypical parathyroid adenoma ie hypercalcemia nephrolithiasis nephrocalcinosis bone mass loss fragility fracture bone pain radiological findings of skeletal complaints gastrointestinal manifestations
Pre-operative instrumental screening of the neck neck ultrasounds parathyroid scintigraphy with 99mTc-Sestamibi neck CT scan 11C-choline PETCT 11C-methionin PETCT 18F-FDG-PETCT
Pre-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism
Pre-operative DXA evaluation of bone status
Pre-operative identification of lymph node andor distant metastases
Pharmacological therapies
Surgical intervention age type clear margins removed lymph nodes complications perioperative mortality etc
Post-operative histological analysis of resected tumor surrounding tissue and vascular invasion Ki67 index mitotic activity nuclear atypia aneuploidy immunostaining of parafibromin and other specific proteins
TMN tumor staging
Somatic genetic screening of resected tumor
Post-operative clinical follow-up serum calcium normalization post-operative hypoparathyroidism episodes of hypocalcemia episodes of hypophosphatemia hungry bone syndrome disease persistence tumor recurrence etc
Post-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism the first check-up after parathyroid surgery and subsequent follow-up measurements
Post-operative instrumental screening of the neck neck ultrasounds parathyroid scintigraphy with 99mTc-Sestamibi neck CT scan 11C-choline PETCT 11C-methionin PETCT 18F-FDG-PETCT
Post-operative DXA evaluation of bone status
Death as a consequence of carcinomaatypical parathyroid adenoma age of death cause
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
Such a database will allow for an epidemiological evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy and to collect case history of patients whose clinical cases will be studied in detail and followed over time up to 10 years after the recruitment in the study also as post-operative follow-up in order to refine knowledge in the field of these two rare and malignant parathyroid tumors to identify the most effective therapy and direct future research in the identification of possible specific therapeutic targets
Specific objectives of the studies are
1 Creation of an Italian centralized multicenter database of patients with parathyroid carcinoma or atypical parathyroid adenoma through the collection of patients at 33 specialist clinical centers of endocrinology and endocrine surgery located throughout the Italian territory and visiting patients from all the 20 regions of Italy
2 Collection of a relatively high number of patients with parathyroid carcinoma or atypical parathyroid adenoma both as sporadic tumors or in the context of genetic disorders
3 Retrospective collection of data about past clinical history of parathyroid carcinoma and atypical parathyroid adenoma at the time of the recruiting visit
4 Continuous and updated prospective collection of patients data over time starting from the first recruiting visit up to 10 years after the recruitment in the study
5 Evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy both as sporadic disease or in the context of genetic disorders
6 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
7 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
8 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
C Study population
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 groupcomparison group or healthy volunteers
Given the extreme rarity of parathyroid carcinoma and atypical parathyroid adenoma we estimate that we will be able to include in the study a minimum of 100 and a maximum of 300 patients affected by parathyroid carcinoma or atypical parathyroid adenoma during the 10 years of the study
Inclusion criteria
Cohort 1 parathyroid carcinoma
Cohort 2 atypical parathyroid adenoma Exclusion criteria
None
D Study design and setting
Non-profit multicenter national retro-prospective observational study consisting in the design creation management and analysis of an Italian database of patients with parathyroid carcinoma or atypical parathyroid adenoma
The study will last 10 years The enrollment of patients with parathyroid carcinoma or atypical parathyroid adenoma the inclusion in the database with retrospective collection of their clinical data and the subsequent prospective collection of clinical follow-up data will take place throughout the duration of the study For the retrospective collection retrospective data on parathyroid carcinoma or atypical parathyroid adenoma will be retrieved from patients medical records at the time of the medical visit that the patient will carry out at the Clinical Center for the evaluation of hisher parathyroid disease regardless of inclusion in this study Prospective data relating to the tumor follow-up will be collected during the subsequent medical follow-up visits scheduled for each patient as part of the clinical management of hisher parathyroid disease regardless of inclusion in this study
Being an observational study this study itself does not involve the administration of any drug nor the use of any medical device nor does it involve additional medical visits clinical analyses or care procedures in addition to those conventionally scheduled for the clinical and therapeutic management of patient affected by parathyroid carcinoma or atypical parathyroid adenoma No participant biospecimens of any type will be collected and retained to perform this study Pharmacological treatments and parathyroid surgery for which data on response to therapy and peri-operative and post-operative outcomes will be collected in the database during the study are those that are conventionally administered and performed in patients with parathyroid carcinoma or atypical parathyroid adenoma in the context of treatment of their pathology regardless of their inclusion in this observational study
All data will be collected anonymously and they will be analyzed as aggregates Data collected in the database will be first processed using descriptive statistics such as frequency tables for categorical data median and quartiles for quantitative data on ordinal scales and mean and standard deviation for quantitative data on metric scales Secondly the correlations between variables will be evaluated using the Pearson correlation index in the case of continuous variables and the chi-square test for categorical variables
E Data and variables
Data collected in the database will include if available in patients medical records
Demographics sex year of birth
Family history of parathyroid carcinomaatypical parathyroid adenoma or other parathyroid diseases in first-degree relatives
Lifestyle habits ie smoke alcohol intake
History of neck irradiation
Clinical history and therapy of hyperparathyroidism prior to diagnosis of parathyroid carcinomaatypical parathyroid adenoma
Presence of comorbidities
Age at diagnosis of parathyroid carcinomaatypical parathyroid adenoma type of diagnosis genetic test if performed
Clinical manifestations of parathyroid carcinomaatypical parathyroid adenoma ie hypercalcemia nephrolithiasis nephrocalcinosis bone mass loss fragility fracture bone pain radiological findings of skeletal complaints gastrointestinal manifestations
Pre-operative instrumental screening of the neck neck ultrasounds parathyroid scintigraphy with 99mTc-Sestamibi neck CT scan 11C-choline PETCT 11C-methionin PETCT 18F-FDG-PETCT
Pre-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism
Pre-operative DXA evaluation of bone status
Pre-operative identification of lymph node andor distant metastases
Pharmacological therapies
Surgical intervention age type clear margins removed lymph nodes complications perioperative mortality etc
Post-operative histological analysis of resected tumor surrounding tissue and vascular invasion Ki67 index mitotic activity nuclear atypia aneuploidy immunostaining of parafibromin and other specific proteins
TMN tumor staging
Somatic genetic screening of resected tumor
Post-operative clinical follow-up serum calcium normalization post-operative hypoparathyroidism episodes of hypocalcemia episodes of hypophosphatemia hungry bone syndrome disease persistence tumor recurrence etc
Post-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism the first check-up after parathyroid surgery and subsequent follow-up measurements
Post-operative instrumental screening of the neck neck ultrasounds parathyroid scintigraphy with 99mTc-Sestamibi neck CT scan 11C-choline PETCT 11C-methionin PETCT 18F-FDG-PETCT
Post-operative DXA evaluation of bone status
Death as a consequence of carcinomaatypical parathyroid adenoma age of death cause
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None