Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
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.
Interventions
OTHERWhole 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)
Sponsors
Progenity, Inc.
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole blood collection | about 3 years | Whole blood collection from 750 healthy subjects total |
Countries
United States
Outcome results
None listed