A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

History of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692223
• Other study ID #: 12-167
• Status: Completed
• Start date: September 2012
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• History of Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress	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.	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center