UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013192
Receipt number R000011760
Scientific Title A retrospective and prospective study for identification of Lynch syndrome by using questionnaire in uterine corpus and ovarian cancer patients
Date of disclosure of the study information 2014/02/18
Last modified on 2016/08/21 10:30:39

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Basic information

Public title

A retrospective and prospective study for identification of Lynch syndrome by using questionnaire in uterine corpus and ovarian cancer patients

Acronym

A retrospective and prospective study for identification of Lynch syndrome by using questionnaire in uterine corpus and ovarian cancer patients

Scientific Title

A retrospective and prospective study for identification of Lynch syndrome by using questionnaire in uterine corpus and ovarian cancer patients

Scientific Title:Acronym

A retrospective and prospective study for identification of Lynch syndrome by using questionnaire in uterine corpus and ovarian cancer patients

Region

Japan


Condition

Condition

Endometrial cancer and ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

questionaire

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

questionaire

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

Diagnosis

Type of intervention

Other

Interventions/Control_1

questionaire

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Female

Key inclusion criteria

Endometrial cancer or ovarian cancer

Key exclusion criteria

questionaire

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryutaro Nishikawa

Organization

Nagoya city univ.

Division name

Obsterrics and Gynecology

Zip code


Address

Kawasumi1 Mizuho-Cho Mizuho-Ku Nagoya-City

TEL

052-853-8241

Email

hidymryu@quartz.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryutaro Nishikawa

Organization

Nagoya city univ.

Division name

Obsterrics and Gynecology

Zip code


Address

Kawasumi1 Mizuho-Cho Mizuho-Ku Nagoya-City

TEL

052-853-8241

Homepage URL


Email

hidymryu@quartz.ocn.ne.jp


Sponsor or person

Institute

KCOG

Institute

Department

Personal name



Funding Source

Organization

KCOG

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

名古屋市立大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 18 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

2013 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 18 Day

Last modified on

2016 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011760


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name