Transition From Research to Disclosure in Human Genetics

NCT00505466 | Completed

• 1 other identifier: BS99-038
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 1

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.

Conditions

Education

Keywords

Human Genetics; Genetic Counseling; Genetic Testing; p53 Mutation; Genetics

Outcome Measures

Primary Outcomes (1)

• Number of Participants Received Pre-test Genetic Counseling

  10 Years

Secondary Outcomes (1)

• Number of participants completing genetic testing for p53

  Baseline to time of follow-up (2 weeks, 6, and 12 months)

Study Arms (1)

Pre-Test Genetic Counseling + Genetic Sample

Behavioral: Genetic Counseling

Interventions

Genetic Counseling BEHAVIORAL

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.

Pre-Test Genetic Counseling + Genetic Sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with cancer or a participant with a family member who has had cancer.

You may qualify if:

• 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.
• 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.
• Psychosocial impact of participating in LFS screening
• Adults who have undergone genetic testing and have a confirmed p53 mutation
• Adults participating in LFS screening program

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Interventions

Genetic Counseling

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louise C. Strong, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: May 6, 1999
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

US (1)