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NCT01320540 · ClinicalTrials.gov registry record
4R for Guideline Indicated BRCA Testing of Breast Center Patients
A clinical trial of Genetic Predisposition to Disease and Newly Diagnosed Carcinoma of Breast, sponsored by Northwestern University.
- Completed
- Registry status
- 75
- Enrollment target
- 1
- Study location
NCT01320540 is a study of Genetic Predisposition to Disease and Newly Diagnosed Carcinoma of Breast that has completed, run by Northwestern University. The registered enrollment target is 75 participants, below the 182,518-participant average among 11 other Genetic Predisposition to Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01320540, a study of Genetic Predisposition to Disease and Newly Diagnosed Carcinoma of Breast, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001). In this study, BRCA testing information will be delivered to patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, and coordinate scheduling with genetic counseling services to insure patients are promptly seen. The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is
Conditions Studied
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01320540
The ClinicalTrials.gov registry entry for NCT01320540 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182,518-participant average among 11 other Genetic Predisposition to Disease trials with a reported enrollment target (100% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Genetic Predisposition to Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01320540 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01320540 about?
NCT01320540 is a clinical study titled "4R for Guideline Indicated BRCA Testing of Breast Center Patients". Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, dec...
What is the current status of trial NCT01320540?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2011-03. Estimated completion is 2016-01.
What conditions does trial NCT01320540 study?
This clinical trial studies the following conditions: Genetic Predisposition to Disease, Newly Diagnosed Carcinoma of Breast.
Who is sponsoring clinical trial NCT01320540?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01320540 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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