UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009338
Receipt number R000010966
Scientific Title Evaluation of genetic counceling in the noninvasive prenatal genetic testing
Date of disclosure of the study information 2012/11/15
Last modified on 2017/05/21 00:11:32

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Basic information

Public title

Evaluation of genetic counceling in the noninvasive prenatal genetic testing

Acronym

NIPT study

Scientific Title

Evaluation of genetic counceling in the noninvasive prenatal genetic testing

Scientific Title:Acronym

NIPT study

Region

Japan


Condition

Condition

pregnant women at risk for fetal aneuploidy

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the quality of the genetic counceling

Basic objectives2

Others

Basic objectives -Others

Evaluate the current status

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

level of understandings on the genetic councelings

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

50 years-old >

Gender

Female

Key inclusion criteria

1. over 35 years old at the time of delivery
2. previous history of birth of baby with aneuploidy
3. pregnant women at risk for fetal aneuploidy screened out by serum test or ultrasound test

Key exclusion criteria

Not desire the test

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Sago

Organization

National center for Child-health and development

Division name

Perinatal Center

Zip code


Address

2-10-1Ookura, Setagaya-ku, Tokyo

TEL

03-3416-0181

Email

sagou-h@ncchd.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiko Sekizawa

Organization

Showa Univ.

Division name

ObGyn

Zip code


Address

1-5-8 Hatanodai Shinagawa

TEL

03-3784-8000

Homepage URL


Email

sekizawa@med.showa-u.ac.jp


Sponsor or person

Institute

NIPT consortium

Institute

Department

Personal name



Funding Source

Organization

Non

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

2012 Year 11 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Of 7,740 women tested, 142 (1.8%) had positive results, 7,594 (98.1%) had negative results, and 4 (0.1%) had results that were not reportable. Of the 142 women who tested positive, 13 cases resulted in intrauterine fetal death, 3 cases refused to confirm by invasive procedure. Of the 126 positive cases confirmed karyotyping, normal karyotype cases were 3 for trisomy 21, 8 for trisomy 18, and 2 for trisomy 13. In the follow-up study of negative cases (n=1,638), one false negative case of trisomy 18 was observed.

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

2012 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 31 Day

Last follow-up date

2015 Year 02 Month 28 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

not started


Management information

Registered date

2012 Year 11 Month 15 Day

Last modified on

2017 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010966


Research Plan
Registered date File name
2017/05/21 Report.docx

Research case data specifications
Registered date File name
2017/05/21 Report.docx

Research case data
Registered date File name
2017/05/21 Report.docx