Whole Blood Specimen Collection From Healthy Subjects

• Conditions: Healthy Volunteers
• Interventions: Other: Whole blood

• Registration Number: NCT02797743
• Lead Sponsor: Progenity, Inc.

Brief Summary

This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-17
• Primary Completion: 2021-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Whole blood from all ages and gender	Whole blood	- Ages from 0 to Adults (18 yrs of age or older)

Primary Outcome Measures

Name	Time	Method
Whole blood collection	about 3 years	Whole blood collection from 750 healthy subjects total

Trial Locations

Locations (3)

Cincinnati Obgyn; 🇺🇸 Cincinnati, Ohio, United States

Heinen Obstetrics & Gynecology; 🇺🇸 Eunice, Louisiana, United States

Virtua Medical Group; 🇺🇸 Voorhees, New Jersey, United States