UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004772
Receipt number R000005609
Scientific Title Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema
Date of disclosure of the study information 2010/12/22
Last modified on 2020/01/21 13:01:06

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Basic information

Public title

Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema

Acronym

Study for new treatment methods and classifications in primary lympedema

Scientific Title

Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema

Scientific Title:Acronym

Study for new treatment methods and classifications in primary lympedema

Region

Japan


Condition

Condition

primary lymphedema

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

study for new treatment methods and classifications in primary lymphedema

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical examinations for lymphedema
functional evaluations for lymph

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

Treatment

Type of intervention

Gene Device,equipment Maneuver

Interventions/Control_1

Period of 5 years
lymphoscintigraphy, fluorescence lymphography once or twice a year and, skin biopsy 1 or 2 times a year and physical examination 3-4 times a year

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

0 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

primary lymphedema

Key exclusion criteria

other lymphedema

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maegawa Jiro

Organization

Yokohama City University Hospital

Division name

Plastic and Reconstructive Surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004

TEL

045-787-2800

Email



Public contact

Name of contact person

1st name
Middle name
Last name Maegawa Jiro

Organization

Yokohama City University Hospital

Division name

Plastic and Reconstructive Surgery

Zip code


Address


TEL


Homepage URL


Email

maegawaj@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University Hospital

Organization

Division

Category of Funding Organization

Other

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

横浜市立大学


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 22 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

Completed

Date of protocol fixation

2010 Year 05 Month 01 Day

Date of IRB

2010 Year 10 Month 01 Day

Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 03 Month 01 Day

Date analysis concluded

2012 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 22 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name