NCT02797743

Whole Blood Specimen Collection From Healthy Subjects

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Progenity, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-07-01
• Primary completion: 2021-07-01
• Completion: 2021-09-01
• First posted: 2016-06-13
• Last updated: 2020-09-17

Locations

3 sites across 1 country: United States