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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
History of Cancer

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Trial Information

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


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).

Type of Study:

Observational

Study Design:

Observational Model: Family-Based, Time Perspective: Prospective

Outcome Measure:

Psychological distress

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mark Robson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-167

NCT ID:

NCT01692223

Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • History of Cancer
  • Personal genomics
  • Genome Sequencing Results
  • 12-167

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021