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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.

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2011-07-05
Est. Completion 2016-01-01

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01582074

The ClinicalTrials.gov registry entry for NCT01582074 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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

NCT01582074 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.