NCT07566780

Brief Summary

The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • cEVTs isolation rate

    To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples

    24 months

Study Arms (1)

Pregnant women

Other: Blood collection

Interventions

Blood collectionOTHER

Samples of peripheral blood (30 ml) will be collected from pregnant women

Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples of peripheral blood (30 ml) will be collected from pregnant women at 8+0 - 14+6 weeks of gestation.

You may qualify if:

  • Informed consent signed before any study-specific procedures
  • Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
  • No medical contraindication for collecting 30 ml blood sample

You may not qualify if:

  • Unable to provide informed consent
  • Known infections that carry a risk of vertical transmission
  • Known maternal viral diseases: HIV and HCV, HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 5, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04