Whole Blood Specimen Collection From Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

Whole Blood Specimen Collection From Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02797743
• Other study ID #: PRO-111-HEALTHY
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: Progenity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: September 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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)

Locations

Country	Name	City	State
United States	Cincinnati Obgyn	Cincinnati	Ohio
United States	Heinen Obstetrics & Gynecology	Eunice	Louisiana
United States	Virtua Medical Group	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Progenity, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole blood collection	Whole blood collection from 750 healthy subjects total	about 3 years