UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Genetic counseling for medical genetics using next-generation sequencing in children's hospital
Title of the study (Brief title)	Genetic counseling for medical genetics using next-generation sequencing in children's hospital
Region	Japan

Condition
Condition	multiple congenital anomalies/developmental delay or intellectual disability
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To determine the information needs in genetic counseling, regarding next-generation DNA sequencing (NGS)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the level of understanding of patient's parents for testing strategy using NGS
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	The parents of patients undergoing the genetic testings using NGS.
Key exclusion criteria	The parents of patients of rejecting the agreement for the genetic testings using NGS.
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Yoshihashi
Organization	Tokyo Metropolitan Children's Medical Hospital
Division name	Department of Medical Genetics
Address	2-8-29 Musashidai Fuchu, Tokyo
TEL	042-300-5111
Email	hiroshi_yoshihasi@tmhp.jp

Public contact
Name of contact person	Hiroshi Yoshihashi
Organization	Tokyo Metropolitan Children's Medical Hospital
Division name	Department of Medical Genetics
Address	2-8-29 Musashidai Fuchu, Tokyo
TEL	042-300-5111
Homepage URL
Email	hiroshi_yoshihasi@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Metropolitan Children's Medical Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	No other information

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2016 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022978