UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058250 |
|---|---|
| Receipt number | R000066588 |
| Scientific Title | Observational Study on the Genomic Profile and Targeted Therapy in Parathyroid Carcinoma (Database Research Utilizing the Center for Cancer Genomics and Advanced Therapeutics (C-CAT)) |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 12:44:33 |
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Basic information
Public title
Observational Study on the Genomic Profile and Targeted Therapy in Parathyroid Carcinoma (Database Research Utilizing the Center for Cancer Genomics and Advanced Therapeutics (C-CAT))
Acronym
Therapeutic target gene for parathyroid cancer (C-CAT)
Scientific Title
Observational Study on the Genomic Profile and Targeted Therapy in Parathyroid Carcinoma (Database Research Utilizing the Center for Cancer Genomics and Advanced Therapeutics (C-CAT))
Scientific Title:Acronym
Therapeutic target gene for parathyroid cancer (C-CAT)
Region
| Japan |
Condition
Condition
Parathyroid carcinoma
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Endocrine surgery |
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to analyze data registered at the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) for parathyroid cancer, a rare cancer, and to exploratory evaluate the genomic profile of parathyroid cancer cases, the frequency of mutations that could be therapeutic targets, and the proportion of cases in which treatment based on the genomic profile was actually recommended.
Basic objectives2
Others
Basic objectives -Others
To investigate the current status of cancer gene panel testing for parathyroid cancer and to explore the characteristics of genome profiles in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genomic profiles of parathyroid cancer cases, frequency of mutations that could be therapeutic targets, and the proportion of cases for which treatment based on genomic profiles was actually recommended
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Parathyroid carsinoma cases registered in the C-CAT database
2) Cases from 2019, when data collection began, to December 2024
Key exclusion criteria
None
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Notsu |
Organization
Shimane University School of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
Shimane prefecture, Izumo city, Enya-cho 89-1Shimane University, Internal Medicine 1
TEL
+81-853-20-2183
mnotsu25@med.shimane-u.ac.jp
Public contact
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 89-1Shimane University, Internal Medicine 1
TEL
+81-853-20-2183
Homepage URL
https://www.shimane-u-internal1.jp/patient/565
mnotsu25@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Japan Center for Cancer Genomic and Advanced Therapeutics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
Shimane prefecture, Izumo city, Enya-cho 89-1
Tel
+81-853-20-2515
kenkyu-dc@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the IRB review at Shimane University is completed, the data will be reviewed and approved by the Information Utilization Review Board at C-CAT, after which a data usage agreement will be concluded, after which the rights to access the utilization search portal will be granted, and access will be possible via TLS connection from the PC of the declarant (principal researcher). The following data will be collected from the C-CAT information of the research subjects.
1) Age, sex, height, weight, BMI, smoking history, drinking history
2) Type of cancer gene panel test
3) Family history (presence or absence of parathyroid cancer)
4) Progress from first consultation to cancer gene panel test, treatments already performed
5) Site of recurrence or metastasis
6) Presence or absence of multiple cancers or overlapping cancers
7) Site of specimen collection, pathological diagnosis, cancer cell content
8) Curation results (tumor gene mutation amount, presence or absence of microsatellite instability, actionable gene abnormality, druggable gene abnormality, type of germline variants and VAF = proportion of cancer cells with specific mutations)
9) Presence or absence of recommended treatment based on genetic profile and its contents
10) Presence or absence of recommended treatment based on comprehensive judgment and its contents
The access right is valid for one year, after which an application for extension of use and contract renewal are required every year.
The purpose of this study is to investigate the actual situation of cancer gene panel tests for parathyroid cancer and explore the characteristics of genome profiles in Japan. Therefore, descriptive statistics will be mainly performed.
Management information
Registered date
| 2025 | Year | 06 | Month | 22 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066588
