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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020550
Receipt No. R000023726
Scientific Title Association of CTNNB1 and APC mutation status with treatment outcome in patients with desmoid-type fibromatosis
Date of disclosure of the study information 2016/01/14
Last modified on 2021/01/19

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Basic information
Public title Association of CTNNB1 and APC mutation status with treatment outcome in patients with desmoid-type fibromatosis
Acronym CTNNB1 mutation analysis in desmoid tumor
Scientific Title Association of CTNNB1 and APC mutation status with treatment outcome in patients with desmoid-type fibromatosis
Scientific Title:Acronym CTNNB1 mutation analysis in desmoid tumor
Region
Japan

Condition
Condition desmoid-type fibromatosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the relationship between CTNNB1 mutation type and treatment outcome in patients with desmoid-type fobromatosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Identify mutation type of CTNNB1, evaluate relationship between mutation type of CTNNB1 and treatment outcome in patients with desmoid-type fibromatosis
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 histological determination as desmoid-type fibromatosis
Key exclusion criteria informed consent not obtained
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishida
Organization Nagoya University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 466-8550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-744-1908
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tomohisa
Middle name
Last name Sakai
Organization Nagoya University Hospital
Division name Orthopaedic Surgery
Zip code 466-8550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-741-2111
Homepage URL
Email tosakai@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University
Address 65-Tusurmai, Showa, Nagoya, 466-8550, Japan
Tel +81527441908
Email ynishida@med.nagoya-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
2016 Year 01 Month 14 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
2015 Year 04 Month 21 Day
Date of IRB
2014 Year 10 Month 30 Day
Anticipated trial start date
2015 Year 04 Month 21 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information clinical outcome of various treatment

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2021 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023726

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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