UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036208 |
|---|---|
| Receipt number | R000041223 |
| Scientific Title | Signification of gene mutational analysis using thyroid biopsy specimens |
| Date of disclosure of the study information | 2019/03/15 |
| Last modified on | 2023/09/19 11:14:10 |
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Basic information
Public title
Signification of gene mutational analysis using thyroid biopsy specimens
Acronym
Diagnosis and Examination by liquid biopsy for thyroid tumor
Scientific Title
Signification of gene mutational analysis using thyroid biopsy specimens
Scientific Title:Acronym
Diagnosis and Examination by liquid biopsy for thyroid tumor
Region
| Japan |
Condition
Condition
Patients with thyroid tumor
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish less invasive diagnostics for thyroid tumor and detection system of genetic mutations in blood and residual samples of fine needle aspiration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of genetic abnomalities such as BRAF mutations in blood and thyroid tissue
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with thyroid tumor
Patients with written informed consent
Key exclusion criteria
Patients with severe heart disease
Patients with severe renal disease
Patients with serious mental illness
Patients complicated with severe infection
Patients with severe diabetes
Patients with other malignant tumors
Patients with severe dehydration and malnutrition
Patients who have other serious complications and are considered difficult to participate
Patients who judged inappropriate by an attendant physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Kunibe |
Organization
Institute of Biomedical Research,Sapporo Higashi Tokushukai Hospital
Division name
Division of Genome Diagnosis Research
Zip code
065-0033
Address
14-3-1,Kita 33-jo Higashi,Higashi-ku,Sapporo,Hokkaido
TEL
011-722-1110
ibr-shth@higashi-tokushukai.or.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ono |
Organization
Institute of Biomedical Research,Sapporo Higashi Tokushukai Hospital
Division name
Division of Genome Diagnosis Research
Zip code
065-0033
Address
14-3-1,Kita 33-jo Higashi,Higashi-ku,Sapporo,Hokkaido
TEL
011-722-1110
Homepage URL
ibr-shth@higashi-tokushukai.or.jp
Sponsor or person
Institute
Institute of Biomedical Research,Sapporo Higashi Tokushukai Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2019 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2019 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041223
