EducationNCT00505466
Transition From Research to Disclosure in Human Genetics
An observational study of Education, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 577 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 1999to 8 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient diagnosed with cancer or a participant with a family member who has had cancer.
Who may be able to join
- 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
- Adults who have undergone genetic testing and have a confirmed p53 mutation
- Adults participating in LFS screening program
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Education
- Being tested
- Genetic Counseling
- Keywords
- Human Genetics, Genetic Counseling, Genetic Testing, p53 Mutation, Genetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Test Genetic Counseling + Genetic Sample | Not described Receives: Behavioral: Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Received Pre-test Genetic Counseling
Measured: 10 Years
Secondary outcomes (1)
Number of participants completing genetic testing for p53
Measured: Baseline to time of follow-up (2 weeks, 6, and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study start6 May 1999
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise C. Strong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505466
- Sponsor's protocol ID
- BS99-038
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2007
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition From Research to Disclosure in Human Genetics
- ClinicalTrials.gov ID
- NCT00505466
- Acronym / sponsor ID
- BS99-038
- Conditions
- Education
- Keywords
- Human Genetics, Genetic Counseling, Genetic Testing, p53 Mutation, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 May 1999 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Test Genetic Counseling + Genetic Sample | – | Behavioral: Genetic Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with cancer or a participant with a family member who has had cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic CounselingGenetic 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. | Behavioural | Pre-Test Genetic Counseling + Genetic Sample |
Primary outcome
Number of Participants Received Pre-test Genetic Counseling
Time frame: 10 Years
1 secondary outcome
Number of participants completing genetic testing for p53
Time frame: Baseline to time of follow-up (2 weeks, 6, and 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise C. Strong, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Education, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Received Pre-test Genetic Counseling (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.