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Transition From Research to Disclosure in Human Genetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505466
First received: July 19, 2007
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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
Study Start Date: May 1999
Estimated Primary Completion Date: May 2016 (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.

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 records.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 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.

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:

N/A

  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 ClinicalTrials.gov identifier: NCT00505466

Contacts
Contact: Louise C. Strong, MD 713-792-7555

Locations
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
Investigators
Principal Investigator: Louise C. Strong, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505466     History of Changes
Other Study ID Numbers: BS99-038
Study First Received: July 19, 2007
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014