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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036208
Receipt No. 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 2019/03/15

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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 Cancer Research
Zip code 065-0033
Address 14-3-1,Kita 33-jo Higashi,Higashi-ku,Sapporo,Hokkaido
TEL 011-722-1110
Email 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 Clinical biological information analysis
Zip code 065-0033
Address 14-3-1,Kita 33-jo Higashi,Higashi-ku,Sapporo,Hokkaido
TEL 011-722-1110
Homepage URL
Email ibr-shth@higashi-tokushukai.or.jp

Sponsor
Institute Institute of Biomedical Research,Sapporo Higashi Tokushukai Hospital
Institute
Department

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
Email 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
2021 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
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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