HDFNNCT02969174
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.
A study testing zimin Lu,Guo Sa in people with HDFN, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 38 weeks
- Conditions the study is for
- HDFN
- What is being tested?
- zimin Lu,Guo Sa
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 38 weeks
- All sexes
- Child
Who may be able to join
- blood samples of pregnant couples,gender/nation/region is unlimited.
Who cannot join
- adipose or hemolytic samples,overdue samples,unidentified samples
About this study
Official title: Clinical Professor of Shanghai Tongji Hospital
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).
Read the detailed description
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.
- Conditions
- HDFN
- Being tested
- zimin Lu,Guo Sa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zimin Lu,Guo SaOther
chengzhong Liu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDFNStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969174
- Sponsor's protocol ID
- ShangjiTongjiHsxk
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Professor of Shanghai Tongji Hospital
- ClinicalTrials.gov ID
- NCT02969174
- Acronym / sponsor ID
- ShangjiTongjiHsxk
- Conditions
- HDFN
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 to 38 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- blood samples of pregnant couples,gender/nation/region is unlimited.
Key exclusion criteria (1 listed)
- adipose or hemolytic samples,overdue samples,unidentified samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zimin Lu,Guo Sachengzhong Liu | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
Related trials for HDFN
RecruitingObservational study
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
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A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
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Not yet recruiting
Prenatal Blood Typing With Next Generation Sequencing (NGS) - an Implementation Study in HDFN (PREFAB)
Red Blood Cell Alloimmunization in Pregnancy, HDFN
RecruitingObservational study
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
s100b, Hypoxia-Ischemia, Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing zimin Lu,Guo Sa in people with HDFN, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.