Skip to main content
OpenTrials
Completed

NCT Number: NCT01692223

A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

History of Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cancer survivors (sample #1):

  • Consented individuals with a personal history of cancer enrolled on protocols 09-068 or 96-051 who have indicated their interest in participating in future research or learning their results, defined as either:
  • For samples #1-2: checking "yes" to the re-contact question in their consent form; or,
  • checking "I wish to know these results" in their consent form.

Unaffected Relatives (sample #2):

  • Consented individuals with no personal history of cancer enrolled on protocols 09-068 and 96-051 (parents or siblings of probands) who have indicated their interest in participating in future research or learning their results, defined as either:
  • checking "yes" to the re-contact question in their consent form or,
  • checking "I wish to know these results" in their consent form

Focus group participants (sample #3- hypothetical group):

  • Individuals with or without a personal history of cancer

Exclusion criteria

  • Non-English speakers; or,
  • Individuals < 18 years of age; or
  • Individuals unable to complete the follow-up assessments (e.g., unavailable to complete questionnaires over the 12-month study period).
  • For samples #1-2: Individuals who indicate in their consent form that they do not want to
  • checking "no" to the re-contact question in their consent form; or,
  • checking "I prefer not to know these results" in their consent form
  • Cases where it is unclear whether individuals' are interested in participating in future research or learning their results, defined as:
  • Not answering the re-contact question in their consent form (i.e., left blank); or,
  • Not answering the re-contact question because it did not exist in the version of the consent form that was originally signed (i.e., re-contact question missing).

Treatment and study plan

Qualitative interviews

Behavioral

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.

Other names: (Continued from Intervention Description) The RSA will call each participant to assess changes in health behavior and, service use at 3-,6- & 12-month timepoints after the results session. Distress, will also be re-assessed at 6 & 12-month timepoints after the results session., The interviewer will call willing participants to complete an open-ended, in-depth, qualitative interview, approximately 3 months after their results session.

Primary outcomes

  1. Psychological distress

    Time frame: 2 years

    of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety & Depression Scale (HADS; score > or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2012
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.