Houston, Texas 77030


Purpose:

Objectives: To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG). The long-term goals of this program are expected to include, but are not limited to the following: 1. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program. 2. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal. 3. To facilitate genetic testing, screening and prevention strategies in those at risk. 4. Establish high-risk cohort for optional participation in research and clinical trials.


Study summary:

Family Member: If you agree to take part in this study: - You will use your online account to access a FamilyCONNECT website in order to communicate with family members about a genetic mutation that has been found in your family. - On the FamilyCONNECT website, you will: - Provide additional information about your family history. This could take up to 20 minutes to complete. - Print an updated copy of the family tree that describes your family. - List other family members who may share this genetic mutation risk, then choose—for each family member—whether you want us to share information about the family's genetic mutation. - Provide contact information for each family member who you want us to contact. This is an investigational study. Up to 130 study participants who have the gene mutation, and their interested family members (up to 10,000 total participants), will be enrolled in this research study. All will be enrolled at MD Anderson. MD Anderson Patient: If you agree to take part in this study: - You will be asked to complete a family history questionnaire online, which should take about 20 minutes to complete. If your family history questionnaire has already been completed with an MD Anderson genetic counselor, the study staff will use this information in the study. - You will create an account to access the online site called FamilyCONNECT that allows you to communicate with family members about your genetic mutation and their risk of having this mutation as well. - On that online site, you will: - Create a user name and password - Provide additional information about your family history. - Print a family tree about your family. - Choose—for each family member—whether you want us to share information about your genetic mutation. - Provide contact information for each family member who you want us to contact. Your personal health information will be collected from your medical record while you are on study. In the future, the study staff will continue to gather health (including genetic) information about you from the institutions for which you have signed the release of medical records. Length of Study: There is no end date planned for the collection of your health information on this study. This is an investigational study. Up to 130 study participants who have the gene mutation, and their interested family members (up to 10,000 total participants), will be enrolled in this research study. All will be enrolled at MD Anderson. Non-MD Anderson Patient: If you agree to take part in this study: - You will create an account to access the online site called FamilyCONNECT that allows you to communicate with family members about your genetic mutation and their risk of having this mutation as well - On that online site, you will: - Create a user name and password - Provide information about your family history, which should take you about 20 minutes to complete. - Print a family tree about your family. - Choose—for each family member—whether you want us to share information about your genetic mutation. - Provide contact information for each family member who you want us to contact. - You will be asked to sign the release of your medical records, including your health information, genetic testing information, and treatments that may have been performed. Your personal health information will also be collected from your medical record while you are on study. In the future, the study staff will continue to gather health (including genetic) information about you from the institutions for which you have signed the release of medical records. Length of Study: There is no end date planned for the collection of your health information on this study. This is an investigational study. Up to 130 study participants who have the gene mutation, and their interested family members (up to 10,000 total participants), will be enrolled in this research study. All will be enrolled at MD Anderson.


Criteria:

Inclusion Criteria: 1. Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry. 2. Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in FAP, or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC). 3. At-risk family members (older than 18 years of age) of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this, as outlined below in section 4.0 Research Plan and Methods. Exclusion Criteria: 1. Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available. 2. Patients who are unwilling or are unable to provide informed consent.


NCT ID:

NCT02337452


Primary Contact:

Principal Investigator
Patrick Lynch, MD, JD
M.D. Anderson Cancer Center

Patrick Lynch, MD, JD
Phone: 713-794-5073


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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