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Transition From Research to Disclosure in Human Genetics

18 Years
Open (Enrolling)

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Trial Information

Transition From Research to Disclosure in Human Genetics

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.

Participants who submit a sample will be required to see a genetic counselor/study
professional 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.

If you have a child under the age of 27, you will fill out survey that will ask about how
you would feel about your child taking part in genetic testing. This survey will take about
15-20 minutes to complete.

You will either fill out this survey over the telephone or it will be mailed to you. If it
is by mail, you will be given a self-addressed stamped envelope to send the survey back to
the study staff.

Participants who decide to know the test results will schedule a telephone conversation with
the genetic counselor/study professional within 2-3 months. This will include more
counseling, with additional follow-up as needed.

The test results and the survey will be kept private. Names will not be used in computer

This is an investigational study. About 800 people will be offered genetic testing. This
study is being performed only at MD Anderson.

Inclusion Criteria:

- 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 115 kindreds including at
least 800 participants living who may be at risk of carrying a p53 germline

- 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.

For the survey portion of this study, we will invite individuals who:

1. are already enrolled in the present study (protocol BS99-038),

2. are at risk for carrying a 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 sign a specific informed consent form (Transition
from Research to Disclosure in Human Genetics, BS99-038, Subtitle: Optional Survey).
The informed consent document for the survey portion of the study will be translated
into the language of the target population for non-English speaking participants in
accordance with the IRB procedures.

Exclusion Criteria:


Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of Participants Received Pre-test Genetic Counseling

Outcome Time Frame:

10 Years

Safety Issue:


Principal Investigator

Louise C. Strong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Education
  • Human Genetics
  • Genetic Counseling
  • Genetic Testing
  • p53 Mutation
  • Genetics



U.T.M.D. Anderson Cancer Center Houston, Texas  77030