Transition From Research to Disclosure in Human Genetics
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00505466|
Recruitment Status : Recruiting
First Posted : July 23, 2007
Last Update Posted : August 15, 2017
The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations with a genetic counselor/study professional.
This is an investigational study. About 800 people will be offered genetic testing. This study is being performed only at MD Anderson.
|Condition or disease||Intervention/treatment|
|Education||Behavioral: Genetic Counseling|
Participants will receive pre-test genetic counseling in one of three ways: (1) in person at MD Anderson; (2) by telephone with an MD Anderson Genetic Counselor/study professional; (3) with a local Genetic Counselor in conference with the MD Anderson Genetic Counselor/study professional. After receiving pre-test genetic counseling, participants will be given the opportunity to schedule a submission of a small sample of blood (about 6 tablespoons) for genetic testing for p53. You may have this blood test repeated if there are any problems in the lab. The study doctor will discuss this with you.
Participants who submit a sample may choose to see a genetic counselor/study professional in person or schedule a phone conversation to receive the results of the genetic test. Genetic counseling may take place at MD Anderson at no cost. Participants may wish to have counseling close to their home, though they then are responsible for the cost of the counseling. If, after talking to the counselor/study professional, the participant wants to know the results of the test, he or she will be told. A participant will be given more counseling and advice on what other care might be needed and what other actions they should take.
The test results will be kept private. Names will not be used in computer records.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Transition From Research to Disclosure in Human Genetics|
|Actual Study Start Date :||May 6, 1999|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
|Pre-Test Genetic Counseling + Genetic Sample||
Behavioral: Genetic Counseling
Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.
- Number of Participants Received Pre-test Genetic Counseling [ Time Frame: 10 Years ]
- Number of participants completing genetic testing for p53 [ Time Frame: Baseline to time of follow-up (2 weeks, 6, and 12 months) ]
Biospecimen Retention: Samples With DNA
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): NCT00505466
|Contact: Louise C. Strong, MD||713-792-7555|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Louise C. Strong, MD|
|Principal Investigator:||Louise C. Strong, MD||M.D. Anderson Cancer Center|