Cell-Based Noninvasive Prenatal Testing

RECRUITING

I'm interested ...!!

The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.

Conditions:

🦠 Pregnancy Related

🗓️ Study Start (Actual) 12 January 2022

🗓️ Primary Completion (Estimated) 12 January 2024

✅ Study Completion (Estimated) 12 March 2024

👥 Enrollment (Estimated) 500

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

Inclusion Criteria for healthy pregnant subjects:
* Pregnant
* 18 years or older
* 65 or younger
Exclusion Criteria for healthy pregnant subjects:
* Acute illness
* Unavailability of maternal blood sample of at least 30 ml
* Language barrier (non-English speaking )
* Maternal age of less than 18 years, or over 65
* Higher order multiple pregnancy (triplet or greater)

Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 February 2022
First Submitted that Met QC Criteria 16 February 2022
First Posted 17 February 2022

Study Record Updates