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Trial record 3 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Genetic Counseling"

Transition From Research to Disclosure in Human Genetics

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 19, 2007
Last updated: August 11, 2017
Last verified: August 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 Intervention
Education Behavioral: Genetic Counseling

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Transition From Research to Disclosure in Human Genetics

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 800
Actual Study Start Date: May 6, 1999
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.


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
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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00505466     History of Changes
Other Study ID Numbers: BS99-038
Study First Received: July 19, 2007
Last Updated: August 11, 2017

Keywords provided by M.D. Anderson Cancer Center:
Human Genetics
Genetic Counseling
Genetic Testing
p53 Mutation
Genetics processed this record on September 20, 2017