MedTrace Logo

A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

NCT01692223 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2018-08-02

No results posted yet for this study

Summary

This study uses new methods called "genome sequencing" that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as "variants." Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer.

The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.

Conditions

  • History of Cancer

Interventions

BEHAVIORAL

qualitative interviews

A week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety \& Depression Scale (HADS), revised Impact of Events Scale (IES-R), \& a questionnaire about their health behaviors, to establish baseline distress levels \& health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider \& discuss resultant therapeutic \& management recommendations for the participants \& their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview.

Sponsors & Collaborators

Principal Investigators

  • Mark Robson, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01692223 on ClinicalTrials.gov