Whole Blood Specimen Collection From Healthy Subjects

September 15, 2020 updated by: Progenity, Inc.
This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Progenity is developing diagnostic products to improve the healthcare of men, women, and children. The commercial objective is to make safe, noninvasive genetic testing available to the public, independent of age and other factors that may contribute to pregnancy or other clinical complications.

Sample specimens will not be used to develop genetic lines and/or DNA banks for cloning. Any samples or remnant specimens remaining may be stored indefinitely for future research programs.

Eligible subjects (or parent/guardian) will provide written informed consent after which basic demographic and clinical data will be obtained and a whole blood sample will be collected. A subject's participation may end immediately after their blood draw. The amount of whole blood drawn at any visit will be based upon age of the subject and test to be performed.

In the event a Subject is pregnant, information regarding the gender of the fetus established by either ultrasound, non-invasive prenatal testing (NIPT) results, or at delivery will be collected. Clinical data regarding any karyotyping procedure that may occur on the fetus will be recorded.

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Heinen Obstetrics & Gynecology
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Virtua Medical Group
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati Obgyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men, pregnant women or children, no age restrictions.

Description

Inclusion Criteria:

  • Subject (or guardian)is willing to provide written informed consent to have up to 50 mL of whole blood collected at a single clinic visit (maximum blood volume will depend on age of subject)
  • Subject is considered healthy (and if pregnant, their pregnancy is progressing normally)
  • If pregnant, Subject is carrying a singleton fetus of 10 to 26 weeks' gestational age inclusive

Exclusion Criteria:

  • Women who are not pregnant
  • If pregnant, pregnancy is non-viable
  • If pregnant, evidence of or suspected fetal anomaly based on ultrasound finding, abnormal 1st trimester screening or abnormal NIPT
  • Immediate family history of a previous fetal aneuploidy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Whole blood from all ages and gender
- Ages from 0 to Adults (18 yrs of age or older)
Other: Whole blood
  • Adults ≥18 yrs of age: up to 50 mL (5 tubes)
  • Adolescents 12-17 yrs of age: up to 30 mL (3 tubes)
  • Children 0-11 yrs of age: single tube (1 tube, 10 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole blood collection
Time Frame: about 3 years
Whole blood collection from 750 healthy subjects total
about 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progenity, Inc.

Investigators

  • Study Director: Peter Stiegler, PhD, Head of clinical affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO-111-HEALTHY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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