Establish a Non-invasive Prenatal Genotyping and Extracti... | NCT02969174

Studies
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.

NCT02969174

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Status

Approved for marketing

Last Update Posted

Nov 21, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

HDFN

Interventions

zimin Lu,Guo Sa

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 3, 2016

First Submission Date that Met QC Criteria

Nov 17, 2016

First Posted Date

Nov 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2016

Last Update Posted Date

Nov 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liming Cheng, The President of Shanghai Tongji Hospital, Shanghai Tongji Hospital, Tongji University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Tongji Hospital, Tongji University School of MedicineOTHER

Collaborators

Not provided

Description Module

Brief Summary

To establish a genotyping and extraction technology of non invasive prenatal diagnosis for fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.

To achieve prenatal accurate identification of fetal blood group genotypes，and provide credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease of newborn (HDN).

Detailed Description

Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
zimin Lu,Guo Sa	Other	chengzhong Liu

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

blood samples of pregnant couples,gender/nation/region is unlimited.

Exclusion Criteria:

adipose or hemolytic samples,overdue samples,unidentified samples

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Weeks

Maximum Age

38 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided