Whole Blood Specimen Collection From Healthy Subjects

NCT ID: NCT02797743

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2021-09-30

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

Whole blood from all ages and gender

\- Ages from 0 to Adults (18 yrs of age or older)

Whole blood

Intervention Type: OTHER

• 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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Progenity, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Stiegler, PhD

Role: STUDY_DIRECTOR

Head of Clinical Affairs

Locations

Heinen Obstetrics & Gynecology

Eunice, Louisiana, United States

Virtua Medical Group

Voorhees Township, New Jersey, United States

Cincinnati Obgyn

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

PRO-111-HEALTHY

Identifier Type: -

Identifier Source: org_study_id