|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505466 |
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.
| Condition | Intervention |
|---|---|
|
Education |
Behavioral: Genetic Counseling |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Transition From Research to Disclosure in Human Genetics |
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.
| Estimated Enrollment: | 371 |
| Study Start Date: | May 1999 |
| Estimated Primary Completion Date: | May 2010 (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.
|
Participants will receive pre-test genetic counseling in one of three ways: (1) in person at M. D. Anderson; (2) by telephone with an M. D. Anderson Genetic Counselor; (3) with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor. 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.
Subjects who submit a sample will be required to see a genetic counselor to receive the results of the genetic test. Genetic counseling may take place at M. D. Anderson at no cost. Subjects 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, 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.
Participants who decide to know the test results will schedule a telephone conversation with the genetic counselor within 2-3 months. This will include more counseling, with additional follow-up as needed.
Test results will be kept private. Names will not be used in computer records.
This is an investigational study. About 371 people will be offered genetic testing. This study is being performed only at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patient diagnosed with cancer or a participant with a family member who has had cancer.
Inclusion Criteria:
Exclusion:
N/A
Contacts and Locations| Contact: Louise C. Strong, MD | 713-792-7555 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Louise C. Strong, MD | |
| Principal Investigator: | Louise C. Strong, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Louise C. Strong, MD/Professor ) |
| Study ID Numbers: | BS99-038 |
| Study First Received: | July 19, 2007 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00505466 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Human Genetics Genetic Counseling Genetic Testing p53 Mutation Genetics |
