UMIN-ICDS 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

Email

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


Email

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


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

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/icdr_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