UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055710 |
|---|---|
| Receipt number | R000063658 |
| Scientific Title | Multi-institutional study to develop domestic NGS panels targeting thyroid tumor 2nd |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2025/10/03 12:39:03 |
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Basic information
Public title
Multi-institutional study to develop domestic NGS panels targeting thyroid tumor 2nd
Acronym
Multi-institutional study to develop domestic NGS panels targeting thyroid tumor 2nd
Scientific Title
Multi-institutional study to develop domestic NGS panels targeting thyroid tumor 2nd
Scientific Title:Acronym
Multi-institutional study to develop domestic NGS panels targeting thyroid tumor 2nd
Region
| Japan |
Condition
Condition
thyroid tumor
Classification by specialty
| Endocrinology and Metabolism | Surgery in general | Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In thyroid tumor genetic mutations that are involved tumor development and progression are reported. Genetic testing that examines all genes related to thyroid tumors at once is linked to the pathological diagnosis of thyroid tumors and is thought to be useful in evaluating the degree of malignancy and determining treatment methods. In this study, we will examine the usefulness of a thyroid tumor-specific NGS gene panel testing system developing in Japan for the pathological diagnosis of thyroid tumors pretreatment.
Basic objectives2
Others
Basic objectives -Others
We will analyze the followings:
To evaluate the sensitivity and specificity of detection of thyroid tumor-related genetic alternations
Results of NGS gene panel testing system
Comparison of clinical and genetic characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the sensitivity and specificity of detection of thyroid tumor-related genetic alternations.
Key secondary outcomes
1.To evaluate the gene analysis of NGS gene panel testing system.
2.To determine the type and frequency of gene mutations in thyroid tumors.
3.To determine the clinical behavior and genetic characteristics of thyroid tumors.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons with thyroid nodule(s) who meet all of the following selection criteria 1) through 3)
1)Those who have been diagnosed with thyroid nodule(s) by ultrasound examination
2)18 years of age or older at the time of obtaining written consent
3)Persons who can give written consent to participate in this study after receiving sufficient explanation
Key exclusion criteria
1)Persons deemed unsuitable as subjects by the principal investigator or physician in charge
2)Minors, and adults who are unable to give their consent due to cognitive impairment or other reasons
Persons with following thyroid nodules
3)Cyst
4)Thyroid nodule under 5mm diameter without any malignant findings
5)Suspicious malignant lymphoma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Yano |
Organization
Tokyo Medical University
Division name
Department of Thoracic and Thyroid Surgery
Zip code
160-0023
Address
6-7-1 Nishishinjuku Shinjuku-ku, Tokyo Japan
TEL
03-3342-6111
yanoyuki@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Yano |
Organization
Tokyo Medical University
Division name
Department of Thoracic and Thyroid Surgery
Zip code
160-0023
Address
6-7-1 Nishishinjuku Shinjuku-ku, Tokyo Japan
TEL
03-3342-6111
Homepage URL
yanoyuki@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Yukiko Yano
Funding Source
Organization
Nasu Institute of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nasu Institute of Medical Sciences
Japan thyroid association Clinically Important Issues Committee 13
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University, institutional review board
Address
6-7-1 Nishishinjuku Shinjuku-ku, Tokyo Japan
Tel
03-3342-6111
IRB@tokyo-med.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
| 2024 | Year | 10 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special mention
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063658
