CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 384 enrolled
Drug / intervention
Whole Genome Sequencing +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01902901
NCT01902901N/ACompleted
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Clinical Implementation of Carrier Status Using Next Generation Sequencing

Kaiser Permanente·interventional·Posted Jul 18, 2013·Updated Apr 17, 2019

In Brief

A clinical study evaluating Whole Genome Sequencing and Carrier status testing for Genetic Disorders. Completed, enrolled 384 participants across 1 site.

Detailed Summary

This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women \& partners) seeking pre-conception carrier testing to assess the impact of the program using Whole Genome Sequencing (WGS). 1. The investigators hypothesize that whole genome sequencing will increase the detection of carrier status for Mendelian recessive and x-linked conditions. 2. The investigators hypothesize that parents will act on the knowledge of their carrier status by making different reproductive choices than parents who do not receive this information. 3. The investigators hypothesize that the psychosocial risks are increased among parents who receive expanded carrier screening using Next Generation Sequencing (NGS) compared with usual care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenetic Disorders
CountriesUnited States
CollaboratorsNational Human Genome Research Institute (NHGRI)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 18, 2013
Enrollment StartJan 1, 2014
Primary CompletionJan 1, 2017
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.0 years ago

Interventions

Whole Genome Sequencinggenetic

Participants will receive Whole Genome Sequencing

Carrier status testinggenetic

Carrier status testing