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NCT00001806 · ClinicalTrials.gov registry record · Phase 3
Methods in Education for Breast Cancer Genetics
A Phase 3 study of Breast Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT00001806 is a Phase 3 study of Breast Cancer and Ovarian Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 170 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001806, a Phase 3 study of Breast Cancer and Ovarian Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
Study Summary
In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer genetics program at the National Naval Medical Center s Breast Care Center. Genetic education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer increased lifetime risks for breast and ovarian cancer, were offered under a Navy IRB-approved study. Sixty participants received education and counseling on that protocol, 49 of whom chose to have genetic testing. The education and counseling, provided by oncology nurses trained in cancer genetics, focused on preparing participants to make well-informed decisions about testing. Included were information on cancer and genetics; hereditary breast/ovarian cancer syndrome; risks, benefits and limitations of BRCA1/BRCA2 testing; and screening and risk reduction options for high-risk individuals. Through our experience with this study, we devised two different methods of providing this information. Both of these methods were well received and appear to be equally effective, as measured by knowledge assessments before and after the sessions and subjective evaluation by the participants. We will now study them in a randomized fashion in the current protocol, to better evaluate whether one method is preferable. Ultimately we hope to be able to make recommendations that will allow for access to genetic education and counseling for more individuals in a more cost efficient manner.
Conditions Studied
Interventions
- OTHER Genetic Education and Counseling
Study Locations (1)
Maryland
- Walter Reed National Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 1999-04-06 |
| Est. Completion | 2017-12-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001806
The ClinicalTrials.gov registry entry for NCT00001806 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Genetic Education and Counseling is the first listed.
NCT00001806 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001806 about?
NCT00001806 is a clinical study titled "Methods in Education for Breast Cancer Genetics". In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer genetics program at the National Naval Medical Center s Breast Care Center. Genetic education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer increased lifetime risks for breast...
What is the current status of trial NCT00001806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 1999-04-06. Estimated completion is 2017-12-06.
What conditions does trial NCT00001806 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT00001806?
The interventions under investigation include: Genetic Education and Counseling (OTHER).
Who is sponsoring clinical trial NCT00001806?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001806 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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