UMIN-CTR Clinical Trial

Public title

Investigation of the Current Treatment Strategies for Patients with Parathyroid Cancer: An Individual Study

Acronym

Investigation of the Parathyroid Cancer

Scientific Title

Investigation of the Current Treatment Strategies for Patients with Parathyroid Cancer: An Individual Study

Scientific Title:Acronym

Investigation of the Parathyroid Cancer

Region

Japan

Condition

Investigation of the Current Treatment Strategies for Patients with Parathyroid Cancer: An Individual Study

Classification by specialty

Endocrinology and Metabolism	Endocrine surgery	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

We will conduct a comprehensive survey of the diagnosis and treatment of parathyroid carcinoma patients in Japan to clarify the current situation.

Basic objectives2

Others

Basic objectives -Others

To date, there has been no strategic examination of the epidemiology (including incidence and prognosis), diagnostic methods, or therapeutic approaches for parathyroid carcinoma. Consequently, it has been difficult to pinpoint the clinical issues that must be addressed to advance treatment development. Therefore, we have planned this survey to clarify the current status of diagnosis and treatment for parathyroid carcinoma patients.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The prognosis of parathyroid carcinoma and the pathophysiological conditions associated with that prognosis.

Key secondary outcomes

Indicators associated with diagnosis
Treatment details

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were diagnosed with or received treatment for parathyroid carcinoma between April 2019 and March 2024.

Key exclusion criteria

None

Target sample size

100

Name of lead principal investigator

1st name	Masakazu
Middle name
Last name	Notsu

Organization

Shimane University Faculty of Medicine

Division name

Internal Medicine 1

Zip code

693-8501

Address

Shimane prefecture, Izumo city, Enya-cho 89-1, Shimane university, Internal medicine 1

TEL

+81-853-20-2183

Email

mnotsu25@med.shimane-u.ac.jp

Name of contact person

1st name	Masakazu
Middle name
Last name	Notsu

Organization

Shimane University Faculty of Medicine

Division name

Internal Medicine 1

Zip code

693-8501

Address

Shimane prefecture, Izumo city, Enya-cho 89-1, Shimane university, Internal medicine 1

TEL

+81-853-20-2183

Homepage URL

Email

mnotsu25@med.shimane-u.ac.jp

Institute

Shimane University

Institute

Department

Personal name

Organization

JSPS KAKENHI Grant

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee, Shimane University Faculty of Medicine

Address

Shimane prefecture, Izumo city, Enya-cho 89-1

Tel

+81-853-20-2515

Email

kenkyu@med.shimane-u.ac.jp

Secondary IDs

YES

Study ID_1

20241203-1

Org. issuing International ID_1

Medical Research Ethics Committee, Shimane University Faculty of Medicine

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2024

Year

01

Month

06

Day

Date of IRB

Anticipated trial start date

2024

Year

01

Month

15

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Proportion of Parathyroid Carcinoma

Proportion of parathyroid carcinoma among cases of primary hyperparathyroidism (based on preliminary survey results)
Diagnosis

Trends in patient backgrounds (age at diagnosis, sex)
Summary of how the carcinoma was discovered
Summary of initial symptoms and findings from various tests at the first visit
Proportion of cases suspected to be parathyroid carcinoma before surgery, and a summary of the most informative findings
Pathology
Summary of pathology diagnoses
Treatment

Summary of surgical procedures, intraoperative examinations, and postoperative treatments
Summary of cancer genome profiling tests
Summary of molecular targeted therapies
Treatment of Hypercalcemia

Utilization rates and effectiveness (outcomes) of each medication (bisphosphonates, elcatonin, anti-RANKL antibodies, CaSR agonists, and corticosteroids)
Clinical Course

Proportion of recurrences and distribution of recurrence timing
Causes of death, and the proportion of hypercalcemia-related deaths among them

Registered date

2025

Year

01

Month

02

Day

Last modified on

2025

Year

01

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064702