Fetal Cell Analysis From Maternal Blood

NCT ID: NCT05671744

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2023-09-30

Brief Summary

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The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

Detailed Description

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Conditions

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Prenatal Screening Pregnancy Related Genetic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Blood samples from pregnant women

Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis

Group Type OTHER

Cell-based non-invasive prenatal testing

Intervention Type OTHER

Blood sampling

Interventions

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Cell-based non-invasive prenatal testing

Blood sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant has a viable singleton or twin pregnancy
* Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
* Participant is at least 18 years old and can provide informed consent

Exclusion Criteria

* Unable to provide informed consent
* Prenatal diagnosis of clinical Chorioamnionitis
* Intake of drugs or exposure to teratogenic agents
* Infections that carry a risk of vertical transmission
* Known maternal viral diseases: HIV and HCV, HBV
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Menarini Biomarkers Singapore

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Bolognesi

Role: CONTACT

+39 051 9944165

Anna Doffini

Role: CONTACT

+39 051 9944253

Facility Contacts

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Enrico Ferrazzi, Prof.

Role: primary

Other Identifiers

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MBS21-CBNIPD-001

Identifier Type: -

Identifier Source: org_study_id

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