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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: Completed study of Genetic Predisposition to Disease and Newly Diagnosed Carcinoma of Breast, sponsored by Northwestern University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

To test an intervention for breast cancer patients with familial/genetic risk by obtaining data on 83 women with breast cancer who were tested before the intervention was implemented and comparing their outcomes to 83 women with breast cancer who were treated after the intervention was implemented. The primary endpoint is the timing of BRCA testing relative to (before or after) definitive breast cancer surgery and the surgical decision (lumpectomy, mastectomy, bi-lateral mastectomy).

Study Locations (1)

Illinois

  • Northwestern Memorial Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2011-03
Est. Completion 2016-01
Northwestern University

1,209 total trials

What the finished NCT01320540 record still lists

NCT01320540 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 182,518-participant average among 11 other Genetic Predisposition to Disease trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Genetic Predisposition to Disease appearing as the primary indexed condition, and to 0 interventions.

NCT01320540 reports a single indexed study location in 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.

Similar trials for Genetic Predisposition to Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01320540's enrollment target sits among peer trials

75 10th of 11 higher than 2 of 11 other Genetic Predisposition to Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Genetic Predisposition to Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01320540, the US trial registry maintained by the National Library of Medicine. NCT01320540 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.