Whole Blood Specimen Collection From Healthy Subjects
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 1/27/2019 |
Start Date: | July 2015 |
End Date: | September 2020 |
Contact: | Zulema Sanchez, BA |
Email: | zulema.sanchez@progenity.com |
Phone: | 760-494-1742 |
This study will obtain whole blood specimens from healthy subjects to be used for research
and development and clinical validation of genetic assays.
and development and clinical validation of genetic assays.
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.
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.
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
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