Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
Behavioral Data
+ behavioral Data
+ behavioral Data
Collected from today forward - ProspectiveFamily-Based
Studying health outcomes within families in order to identify genetic or familial contributions to disease.Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Family-Based
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps