NCT05789680

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

March 16, 2023

Last Update Submit

March 16, 2023

Conditions

Keywords

parathyroid carcinomaprimary hyperparathyroidismEurocrine

Outcome Measures

Primary Outcomes (1)

  • Incidence of parathyroid carcinoma

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

    January 2015-January 2021

Secondary Outcomes (1)

  • Oncologic outcome

    January 2015-January 2021

Study Arms (1)

Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism

All adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for primary hyperparathyroidism and received histopathologic diagnosis of parathyroid carcinoma from 2015 till 2021 will be included

Procedure: Surgical treatment of parathyroid carcinoma

Interventions

Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.

Also known as: parathyroidectomy, ipsilateral hemithyroidectomy, ipsilateral central neck dissection
Parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with final histology of parathyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021

You may qualify if:

  • 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

You may not qualify if:

  • Patients \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Parathyroid NeoplasmsHyperparathyroidism, Primary

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid DiseasesHyperparathyroidism

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Raffaelli, Prof

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

December 15, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-02

Locations