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Whole Genome Sequencing clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01927770 Completed - Clinical trials for Whole Genome Sequencing

A Study of Consent Forms for Whole Exome and Whole Genome Sequencing

Start date: December 16, 2013
Phase:
Study type: Observational

Background: The purpose of this study is to investigate the process of consenting participants to whole exome/genome sequencing and its outcomes. It is unknown how best to consent people to this new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a companion to other NIH studies that involve genomic sequencing. Participants must be enrolled in a parent NIH study that is collaborating on this consent study to be eligible. Currently this involves only one NIH study. Objectives: - To learn the best way to help participants understand sequencing, so they can decide whether to join studies that use it. Eligibility: - Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH) study that uses WES/WGS. - Adults at least 18 years old whose children are enrolled in an NIH study that uses WES/WGS. Design: - Participants will take part in the study either in person or over the phone. - Participants will review two sequencing consent forms with a genetic counselor. - Before and after meeting with the counselor, participants will answer several questions about sequencing. Each questionnaire will take about 15 minutes. - Six weeks later, participants will answer questions about sequencing. This will take about 15 minutes.