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Massive newborn genome project aims to map China's genetic future

NCT ID NCT03931707

Knowledge-focused Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This project will sequence the genes of 100,000 newborns in China over five years. The goal is to create a large genetic database, find how often gene changes occur, and improve testing for inherited diseases. Participants are healthy babies under 28 days old with Chinese parents.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The subjects were all from all the member organizations participating in the China Newborn Genome Project. They were hospitalized in the neonatal department of each member hospital.

Ages

Up to 28 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Both parents are of Chinese origin; * 2\. Postnatal age less than 28 days; * 3\. Can be retained to at least 1ml venous blood sample; * 4\. Biological parent or guardian's informed consent. Exclusion Criteria: * 1\. the nationality of one of the parents is not the Han nationality or other national minorities; * 2\. reluctance of parents to use genetic sequencing data for subsequent research; * 3\. parents under 18 years of age or incapacitated for decision-making; * 4\. subjects older than 28 days. * 5\. multiple pregnancies; * 6\. lack of access to biological samples from which DNA can be extracted; * 7\. failure to sign informed consent

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities hereditary disease inherited disease susceptibility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Defect, congenital Genetic predisposition to disease Hereditary disease Newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201102, China

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