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NCT01582074 · ClinicalTrials.gov registry record

The Ultrasound Study of Tamoxifen

A clinical trial, sponsored by National Cancer Institute (NCI).

Completed
Registry status
247
Enrollment target

NCT01582074: Completed study, sponsored by National Cancer Institute (NCI).

NCT01582074 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 247 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01582074 has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
247 participants
Enrollment target

Study Summary

Background: \- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography scans can show changes in breast density. To examine these changes, healthy volunteers with no history of breast cancer and women who are taking tamoxifen will have ultrasound tomography scans. Objectives: \- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure. Eligibility: \- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer. Design: * All participants will have a screening visit. Healthy volunteers will have one additional study visit; women taking tamoxifen will have three additional study visits. * All participants will be screened with a physical exam and medical history. They will also give blood and saliva samples. This visit will also include an initial ultrasound tomography breast scan. * For the healthy volunteers: * At the study visit (12 months after the screening visit), participants will have a short interview and be weighed. They will also have an ultrasound tomography breast scan and provide a blood sample. * For the women taking tamoxifen: * At the second and third visits (1 to 3 months and 3 to 6 months after starting tamoxifen), participants will have a short interview. They will also be weighed and have an ultrasound tomography breast scan. * At the fourth visit (12 months after starting tamoxifen), participants will have a short interview, weight measurement, and the ultrasound tomography breast scan, and will also provide a blood sample. * All participants may be followed for up to 5 years after their final study visit.

Primary Outcome

Change in breast density

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2011-07-05
Est. Completion 2016-01-01
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01582074 record still lists

NCT01582074 is an observational study that tracks outcomes without assigning an intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01582074 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01582074 about?

NCT01582074 is a clinical study titled "The Ultrasound Study of Tamoxifen". Background: \- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography...

What is the current status of trial NCT01582074?

This trial is currently completed. The enrollment target is 247 participants. The study started on 2011-07-05. Estimated completion is 2016-01-01.

Who is sponsoring clinical trial NCT01582074?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01582074, the US trial registry maintained by the National Library of Medicine. NCT01582074 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.