UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020550
Receipt number 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 2023/07/20 09:59:14

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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 or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Significant association was observed between surgical outcome and CTNNB1 mutation

Results date posted

2023 Year 07 Month 20 Day

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

2023 Year 07 Month 20 Day



Link to view the page

Value
https://center6.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