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The Ultrasound Study of Tamoxifen

NCT01582074 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 247

Last updated 2020-12-28

No results posted yet for this 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.

Conditions

  • Breast Neoplasms

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Gretchen Benson, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-05
Primary Completion
2015-12-31
Completion
2016-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582074 on ClinicalTrials.gov