UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019320 |
|---|---|
| Receipt number | R000022332 |
| Scientific Title | The nuclear expression of beta-catenin 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 01:49:56 |
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Basic information
Public title
The nuclear expression of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam
Acronym
The nuclear expression of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam
Scientific Title
The nuclear expression of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam
Scientific Title:Acronym
The nuclear expression of beta-catenin as a prognostic marker of sporadic desmoid tumors with meloxicam
Region
| Japan |
Condition
Condition
sporadic desmoid tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence of beta-catenin nuclear positivity as a prognostic factor in desmoid tumors with meloxicam, a cyclooxygenase-2 (COX-2) selective inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
beta-catenin nuclear positivity
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
31
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
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
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
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
Higher nuclear expression of beta-catenin was detected in all cases and associated with worse non-responder (PD/SD) compared to responder (CR/PR) significantly.
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 | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | 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=R000022332
