Open Actively Recruiting

Women Informed to Screen Depending on Measures of Risk (Wisdom Study)

About

Brief Summary

The WISDOM Study is designed to end the confusion about breast cancer screening. By comparing two safe and accepted screening recommendations, we will determine how to best screen every woman. As part of the study we will be comparing a risk based or more personalized breast cancer screening strategy to annual screening to determine if risk based screening is as safe, less morbid, enables prevention, and is accepted by women. You can self-select the study group you want to be part of or select to be randomized to a group. If you are in the Routine Annual Screening group: 

  • You will answer several questionnaires. We will ask you questions about your health history.

  • We will encourage you to have an initial screening mammogram, or return for your next mammogram one year from the date of your most recent mammogram.

  • If our team believes you are at higher than average risk for breast cancer, you will receive a copy of your detailed risk report. You will be offered the opportunity to discuss your risk with a Breast Health Specialist over the phone. A Breast Health Specialist is an individual who has specialized training in breast cancer risk assessment and genetics. Your Specialist may recommend follow-up activities, such as more frequent screening, or suggest ideas about how you may lower your risk for breast cancer.

  • We will ask you to complete follow-up questionnaires every year to see if there are any changes to your family cancer history, personal history and health status. If you are in the Personalized Screening group:

  • You will complete a series of questionnaires and provide a saliva sample to look for inherited (genetic) risk factors for breast cancer. This test will include 9 genes (including BRCA1 and BRCA2), and a collection of single nucleotide polymorphisms, or SNPS, that have been associated with risk of breast cancer. Please see the FAQs on genetic testing for further detail.

  • You will receive a screening recommendation that is based on the results of your answers to the questionnaire, your mammographic breast density, and your genetic testing results. This screening recommendation letter indicates when you should return for your next mammogram based on whether you are at higher than average, average, or lower than average risk of developing breast cancer. You could be asked to return in 6 months, 1 year, 2 years, or recommended to wait until you turn 50 to start screening (if you are not 50 already).

  • If you are determined to be at elevated risk, you will receive a call from a Breast Health Specialist. S(he) may make recommendations about how you may reduce your risk for breast cancer.

  • We will ask you to complete follow-up questionnaires every year to see if there are any changes to your family cancer history, personal history and health status. You can join the WISDOM Study if you:

  • are a female, age 40-74
  • have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS) -You have not had both breasts surgically removed (prophylactic double mastectomy)

Primary Purpose
Screening
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Female
Healthy Volunteers
Yes
Minimum Age
40 Years
Maximum Age
74 Years

Eligibility: Adult female, age 40-74, no previous breast cancer For more information about the eligibility criteria for this trial Visit www.wisdomstudy.org or call UCLA WISDOM Study coordinating team at 310-794-0981

Inclusion Criteria:

  • Female (biologically female at birth)
  • Age 40 years old to 74 years old

Exclusion Criteria:

  • Prior breast cancer or DCIS diagnosis
  • Non-English or Spanish proficiency (Spanish added June 2019)

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
16-001323
Category
Hematology-Oncology
Oncology
Contact
Antonia Petruse
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02620852
For detailed technical eligibility, visit ClinicalTrials.gov.