UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019321
Receipt number R000022333
Scientific Title The CTNNB1 mutaion as a prognostic marker of sporadic desmoid tumors with meloxicam
Date of disclosure of the study information 2015/10/13
Last modified on 2015/10/13 01:51:02

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Basic information

Public title

The CTNNB1 mutaion as a prognostic marker of sporadic desmoid tumors with meloxicam

Acronym

The CTNNB1 mutaion of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam

Scientific Title

The CTNNB1 mutaion as a prognostic marker of sporadic desmoid tumors with meloxicam

Scientific Title:Acronym

The CTNNB1 mutaion of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam

Region

Japan


Condition

Condition

sporadic desmoid tumor

Classification by specialty

Hematology and clinical oncology Orthopedics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To determine the significance of CTNNB1 (beta-catenin) mutations to predict treatment outcome in patients with desmoid tumors treated with meloxicam

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

CTNNB1 exon3 mutation
efficacy of meloxicam treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Meloxicam was administered orally at 10 mg/day

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

patients with extra abdominal, sporadic desmoid tumors were treated with meloxicam as a systemic medical therapy

Key exclusion criteria

familial adenomatous polyposis-associated desmoid tumor

Target sample size

33


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Nishida

Organization

Nagoya University Graduate School and School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

65 Tsurumai, Showa-ku, Nagoya

TEL

052-744-1908

Email

nishida@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Hamada

Organization

Nagoya University Graduate School and School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

65 Tsurumai, Showa-ku, Nagoya

TEL

052-744-1908

Homepage URL


Email

shamada@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Nagoya University Graduate School and School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Surgery, Nagoya University Graduate School and School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 10 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

All 4 cases with S45F mutation showed PD, and no cases in favorable group (0/20 cases) had S45F mutation(p=0.017), whereas cases with T41A or wild type did not show significant association with efficacy of meloxicam.

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

Completed

Date of protocol fixation

2003 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2003 Year 01 Month 01 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2013 Year 04 Month 30 Day

Date trial data considered complete

2013 Year 05 Month 31 Day

Date analysis concluded

2013 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 13 Day

Last modified on

2015 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name