A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

Completed

Conditions studied: History of Cancer

In brief

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.

Key facts

Study ID

NCT01692223

Run by

Memorial Sloan Kettering Cancer Center

People needed

8

Starts

2012-09-01

Expected to finish

2018-08-01

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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