UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035810 |
|---|---|
| Receipt number | R000040796 |
| Scientific Title | Study for usability of cell free DNA in maternal plasma to detect fetal aneuploidy |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2022/01/20 11:10:51 |
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Basic information
Public title
Study for usability of cell free DNA in maternal plasma to detect fetal aneuploidy
Acronym
Study for usability of cell free DNA in maternal plasma to detect fetal aneuploidy
Scientific Title
Study for usability of cell free DNA in maternal plasma to detect fetal aneuploidy
Scientific Title:Acronym
Study for usability of cell free DNA in maternal plasma to detect fetal aneuploidy
Region
| Japan |
Condition
Condition
fetal aneuploidy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the causes for false positive / false negative, or not reportable in non-invasive prenatal test
Basic objectives2
Others
Basic objectives -Others
usability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detecting the factors for causing false positive / false negative, or not reportable
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
NIPT
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
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant woman in 10+0~21+6 weeks of gestation
and
35 years old or more,
or fetal aneuploidy in previous pregnancy,
or suggested fetal aneuploidy by other prenatal test
Key exclusion criteria
apparent fetal morphological anomaly
who cannot visit hospital
who won't enter this clinical trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kato |
Organization
Kyushu University Hospital
Division name
Research Center for Environment and Development Medical Sciences
Zip code
812-8582
Address
3-1-1 maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5391
kkato@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University
Division name
Department of Obstetrics and Gynecology
Zip code
812-8582
Address
3-1-1 maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5395
Homepage URL
ogawa.masanobu.604@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Kyushu University Institutional Review Board for Clinical Trials
Address
3-1-1 maidashi, Higashi-ku, Fukuoka, Japan
Tel
+81-92-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
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
| 2019 | Year | 02 | Month | 08 | 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
| 2019 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040796
