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Trial record 2 of 20 for:    secure registry

The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02337452
Recruitment Status : Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Advanced Cancers Anal Cancer Colorectal Cancer Gastrointestinal Cancer Behavioral: Family History Questionnaire Behavioral: Web-Based Family Outreach Registry

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration: 40 Years
Official Title: The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families
Actual Study Start Date : April 10, 2015
Estimated Primary Completion Date : April 2048
Estimated Study Completion Date : April 2048

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Relative of MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Non-MDA Participant with Genetic Mutation
Participants complete a family history questionnaire online, which should take about 20 minutes to complete. Participants also taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.
Behavioral: Family History Questionnaire
Participants complete a family history questionnaire online or hardcopy, which should take about 20 minutes to complete.
Other Name: Survey
Behavioral: Web-Based Family Outreach Registry
Participants taught how to use the Web-Based Family Outreach Registry. They will be given a secure log-in username and password for the web site.


Outcome Measures

Primary Outcome Measures :
  1. Web-Based Family Outreach Registry [ Time Frame: Continual assessment of data over participant's life time (Target Follow-Up Duration: 40 Years) ]
    Data analysis for core functions of the web-based Family Outreach Registry will generally be descriptive. Web-based program to improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants with genetic abnormalities and their families at MD Anderson Cancer Center in Houston, Texas
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337452


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Patrick Lynch, MD, JD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02337452     History of Changes
Other Study ID Numbers: 2014-0715
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Hereditary cancer-causing mutation
Gene mutation
Family member with genetic mutation
Questionnaire
Surveys
Registry
Database
Communication

Additional relevant MeSH terms:
Colorectal Neoplasms
Anus Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Rectal Neoplasms
Anus Diseases