UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033341
Receipt No. R000037499
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Histological study on coating formation in tissue expander and silicon breast implant
Title of the study (Brief title) 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 Masahiro Tachi
Organization Graduate School of Medicine, Tohoku University
Division name Department of Plastic and Reconstructive Surgery
Address 2-1, Seiryo-machi, Aoba-ku, Sendai
TEL 0227177748
Email tachi@med.tohoku.ac.jp

Public contact
Name of contact person Yoshimichi Imai
Organization Graduate School of Medicine, Tohoku University
Division name Department of Plastic and Reconstructive Surgery
Address 2-1, Seiryo-machi, Aoba-ku, Sendai
TEL 0227177748
Homepage URL
Email yo-imai@med.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.