UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033341 |
|---|---|
| Receipt number | R000037499 |
| Scientific Title | Histological study on coating formation in tissue expander and silicon breast implant |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2018/07/09 17:59:10 |
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Basic information
Public title
Histological study on coating formation in tissue expander and silicon breast implant
Acronym
Histological study on coating formation
Scientific Title
Histological study on coating formation in tissue expander and silicon breast implant
Scientific Title:Acronym
Histological study on coating formation
Region
| Japan |
Condition
Condition
breast cancer, after brest cancer surgery, after mastectomy
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Histological studies of the capsules formed in tissue expander and silicon breasts implant will examine the association with capsular contracture.
Basic objectives2
Others
Basic objectives -Others
molecular pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory cells, inflammatory cytokines, presence of biofilm, etc.
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
Female
Key inclusion criteria
Patient who wishes breast reconstruction among breast cancer patients and uses tissue expander and silicon breast implant for reconstruction. There is no limitation on the stage of breast cancer.
Key exclusion criteria
Exclude those who do not agree with this research.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tachi |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177748
tachi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Imai |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177748
Homepage URL
yo-imai@med.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
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
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
| 2018 | Year | 07 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2018 | Year | 07 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037499
