NCT02430584

Unknown

Whole Blood Specimen Collection From Pregnant Subjects

Progenity, Inc.Source

Other study identifiers

Sponsor study identifier

PRO-101-SAMPLES

Study Type

observational

Estimated enrollment

5,000

Locations

1 country

Sites

1

Timeline

Study Start

March 2015

Actual (reported)

Primary Completion

March 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

May 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 5,000 participants
Study completion date: May 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2015
Actual (reported)
First Submitted
April 27, 2015
Actual (reported)
First Posted
April 30, 2015
Actual (reported)
Primary Completion
March 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 17, 2020
Status Verified: September 2020
Last Update Submitted: September 15, 2020

Conditions

DiGeorge Syndrome Down Syndrome Edwards Syndrome Klinefelter Syndrome Patau Syndrome Perinatal Infections Turner Syndrome

Outcome Measures

Primary Outcomes (1)

Whole blood collection
One or more monthly clinic visits (≥25 days apart) over 13 weeks

Interventions

Observational - no interventionOther

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older

You may qualify if:

Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits

Sponsors & Collaborators

Progenity, Inc.
Industrylead

Study Sites (1)

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403, United States

Biospecimen

Retention: SAMPLES WITH DNA

Study will collect up to 50 mL of whole blood at one or more monthly clinic visits (≥25 days apart) from pregnant women carrying a single fetus of 10 to 26 weeks of gestational age

MeSH Terms

Conditions

Down SyndromeTrisomy 18 SyndromeTrisomy 13 SyndromeKlinefelter SyndromeTurner SyndromeDiGeorge Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type: observational
Observational Model: FAMILY BASED
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

March 2015

Actual (reported)

Primary Completion

March 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive

Subject is 18 years of age or older

Subject is at an increased risk for one or more of the following:

fetal gene and chromosome abnormalities

congenital fetal infection

known to possess irregular blood group antigens (subject or father of the baby)

known to have some other condition amenable to noninvasive prenatal testing

You may not qualify if:

Pregnancy is non-viable

Contact the study team to confirm eligibility.

Heart Defects, Congenital

Cardiovascular Abnormalities

Cardiovascular Diseases

Heart Diseases

Sex Chromosome Disorders of Sex Development

Disorders of Sex Development

Urogenital Abnormalities

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Urogenital Diseases

Male Urogenital Diseases

Sex Chromosome Disorders

Gonadal Disorders

Endocrine System Diseases

Hypogonadism

Gonadal Dysgenesis

22q11 Deletion Syndrome

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Musculoskeletal Diseases

Lymphatic Abnormalities

Lymphatic Diseases

Hemic and Lymphatic Diseases

Hypoparathyroidism

Parathyroid Diseases

Study Completion

May 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

September 17, 2020

Record last verified: 2020-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02430584
Data provider: ClinicalTrials.gov
Source updated: 2020-09-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:00 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations