UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014851
Receipt number R000017263
Scientific Title Retrospective clinical study of gynecology Cancer Immuno-Cell Therapy study group
Date of disclosure of the study information 2014/08/12
Last modified on 2016/02/15 09:39:26

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Basic information

Public title

Retrospective clinical study of gynecology Cancer Immuno-Cell Therapy study group

Acronym

Retrospective clinical study of gynecology Cancer Immuno-Cell Therapy study group

Scientific Title

Retrospective clinical study of gynecology Cancer Immuno-Cell Therapy study group

Scientific Title:Acronym

Retrospective clinical study of gynecology Cancer Immuno-Cell Therapy study group

Region

Japan


Condition

Condition

Gynecologic tumor

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effectiveness of the Immuno-Cell Therapy for gynecology Cancer (ovarian cancer, endometrial cancer, cervical cancer, and uterine sarcoma)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Overall Survival
Disease Control Rate
Objective Response Rate
Effective water ratio

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients was carried out Immuno-Cell Therapy with Study Group

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoru Takeda

Organization

Juntendo University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code


Address

Hongo 3-1-3, Bunkyo-ku, Tokyo , Japan

TEL

03-3813-3111

Email

stakeda@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhisa Terao

Organization

Juntendo University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code


Address

Hongo 3-1-3, Bunkyo-ku, Tokyo , Japan

TEL

03-3813-3111

Homepage URL


Email

yterao@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Hospital
Department of Obstetrics and Gynecology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

St. Marianna University School of Medicine
Kyoundo Hospital
Seta Clinic Group

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

2014 Year 08 Month 12 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

2014 Year 08 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 12 Day

Last follow-up date


Date of closure to data entry

2015 Year 12 Month 28 Day

Date trial data considered complete

2016 Year 01 Month 31 Day

Date analysis concluded



Other

Other related information

we consider if there is a secondary evaluation


Management information

Registered date

2014 Year 08 Month 12 Day

Last modified on

2016 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017263


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name