UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048211 |
|---|---|
| Receipt number | R000054909 |
| Scientific Title | Multi-institutional registry study of the results of the Oncomine Dx Target Test Multi-CDx system analysis for thyroid cancer |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/12/31 17:48:39 |
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Basic information
Public title
Multi-institutional registry study of the results of the Oncomine Dx Target Test Multi-CDx system analysis for thyroid cancer
Acronym
Multi-institutional registry study of the results of the Oncomine Dx Target Test Multi-CDx system analysis for thyroid cancer
Scientific Title
Multi-institutional registry study of the results of the Oncomine Dx Target Test Multi-CDx system analysis for thyroid cancer
Scientific Title:Acronym
Multi-institutional registry study of the results of the Oncomine Dx Target Test Multi-CDx system analysis for thyroid cancer
Region
| Japan |
Condition
Condition
thyroid cancer
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Thyroid cancer is known to have a high frequency of mutations in driver genes; however, there have been no data to analyze a large number of cases in Japan so far. Serpercatinib and its companion diagnostic system, Oncomine Dx, have been approved to treat advanced or recurrent thyroid cancer in 2022. It is expected that genetic analysis of thyroid cancer using OncomaIn Dx is going to be performed at many institutions from now on.
The registration of the results of OncomaIn Dx analysis from across Japan will enable analysis of the status of genetic mutations in advanced thyroid cancer in Japan, for which limited information was available until now. Furthermore, the information obtained by this registration study is expected to provide helpful knowledge for clinical practice in thyroid cancer.
Basic objectives2
Others
Basic objectives -Others
By accumulating data from the analysis of Oncomine Dx, we will be able to analyze the followings:
(1) Association between response to radioiodine therapy and genetic mutations in differentiated thyroid cancer in Japan
(2) Genetic mutations in undifferentiated cancers in Japan
(3) Genetic mutations of advanced medullary carcinoma in Japan
(4) Genetic mutations of patients previously treated with multi-kinase inhibitors
This study is expected to provide information on advanced thyroid cancer and is of high clinical significance.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the frequency of genetic mutations in each pathological type of advanced thyroid cancer in Japan.
Key secondary outcomes
(1) To determine the association between genetic mutations in differentiated thyroid cancer and response to radioiodine therapy.
(2) To determine the type and frequency of gene mutations in patients previously treated with multi-kinase inhibitors.
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
| 12 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who meet all of the following selection criteria (1) through (4)
(1) Those who meet any of the following
1) Those diagnosed with differentiated thyroid cancer that is not curable by radical resection
2)) Those diagnosed with anaplastic thyroid cancer
3) Those diagnosed with medullary thyroid cancer that cannot be radically resected.
(2) Patients who have undergone or are scheduled to undergo Oncomine Dx to determine if serpercatinib is indicated.
(3) 12 years of age or older at the time of obtaining written consent
(4) 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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Ito |
Organization
Shinshu University School of Medicine
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2656
kenito@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Hara |
Organization
Data Center for Oncomine DxTT Accumulation Study on Thyroid Cancer
Division name
Clinical Research Support Center, Shinshu University Hospital
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2657
Homepage URL
hara_amane@shinshu-u.ac.jp
Sponsor or person
Institute
Japan Association of Endocrine Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Endocrine Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine, Faculty of Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
kitamura_junichi@gm.shinshu-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
| 2022 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observation and examination items
1. Information at registration: date of birth, gender
2. Clinical information
(1) Histopathological type of thyroid cancer
(2)Clinical stage and TNM classification at the time of initial diagnosis
(3) Treatment prior to performing Oncomine Dx testing
(1) Surgery prior to performing Oncomine Dx testing
(2) Radioiodine therapy (only for differentiated thyroid cancer) prior to performing Oncomine Dx testing
(iii) External irradiation prior to performing Oncomine Dx testing
Molecular targeted therapy prior to performing Oncomine Dx testing
(5) Chemotherapy prior to performing Oncomine Dx testing
(6) Other treatment prior to performing Oncomine Dx testing
(4) Organ(s) with tumor at the time of performing Oncomine Dx testing
(5) Site and date of collection of tumor tissue submitted for Oncomine Dx
3. Oncomine Dx analysis result report: success or failure of analysis, presence or absence of mutations in 46 genes: details of mutation
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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