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. Identifier: NCT00505466
Recruitment Status : Recruiting
First Posted : July 23, 2007
Last Update Posted : August 15, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

Detailed Description:

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
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of Participants Received Pre-test Genetic Counseling [ Time Frame: 10 Years ]

Secondary Outcome Measures :
  1. 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
Optional small sample of blood (about 6 tablespoons) for genetic testing for p53 following pre-test genetic counseling.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with cancer or a participant with a family member who has had cancer.

Inclusion Criteria:

2.0 Genetic testing

Members of families who have participated in the p53 project through Dr. Strong's lab are eligible, via protocol P90-001. There are at least 145 kindreds including at least 800 participants living who may be at risk of carrying a p53 germline mutation. The participants must provide an informed consent and be 18 years or older. We will include English and non-English speaking participants. For non-English speaking participants to be recruited, the consent documents has been translated into the language of the target population in accordance with the IRB procedures.

2.1 Parents Attitudes toward testing children at risk for TP53 mutations

For the survey portion of this study, we will invite individuals who 1) are already enrolled in the P90-001 study), 2) have been known to carry a germline p53 mutation, and 3) have children who are less than 27 years old. Patients who agree to enroll in the survey portion of the study will be presented with a consent statement and a printed copy of the survey along with a postage-paid envelope which they can return (either by mail or in person) at their convenience.

2.2 Psychosocial impact of participating in LFS screening

  1. Adults who have undergone genetic testing and have a confirmed p53 mutation
  2. Adults participating in LFS screening program

Exclusion Criteria:

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 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         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Louise C. Strong, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00505466     History of Changes
Other Study ID Numbers: BS99-038
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
Human Genetics
Genetic Counseling
Genetic Testing
p53 Mutation