Clinical Follow-up of Pregnant Subjects Undergoing NIPT | NCT04595201

Studies
Clinical Follow-up of Pregnant Subjects Undergoing NIPT

NCT04595201

Sponsor

Sequenom, Inc.

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

NIPT

Countries

United States

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2020Actual

Primary Completion Date

Oct 13, 2025Estimated

Completion Date

Oct 13, 2025Estimated

First Submitted Date

Oct 14, 2020

First Submission Date that Met QC Criteria

Oct 19, 2020

First Posted Date

Oct 20, 2020Actual

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

Oct 11, 2024

Last Update Posted Date

Oct 16, 2024Actual

Name	Class
Integrated Genetics	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

Detailed Description

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
NIPT	Device	Non-invasive pregnancy testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIPT clinical outcome performance	Sensitivity	9 months
NIPT clinical outcome performance	Specificity	9 months
NIPT clinical outcome performance	Positive predictive value	9 months
NIPT clinical outcome performance	Negative predictive value	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject was pregnant and received NIPT from Sequenom/Integrated Genetics
Subject was 18 years of age or older at the time of NIPT
Pregnancy outcome is available

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Follow-up of pregnant subjects who have undergone NIPT

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kimberly Fanelli, MS, CGC	Contact	603-714-5063		kimberly.fanelli@integratedgenetics.com

Overall Officials

Name	Affiliation	Role
Kimberly Fanelli, MS, CGC	Integrated Genetics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrated Genetics	Recruiting	Westborough	Massachusetts	01581	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided