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Women Informed to Screen Depending on Measures of Risk (WISDOM)

This study is currently recruiting participants.
Verified November 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02620852
First Posted: December 3, 2015
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Patient-Centered Outcomes Research Institute
Robert Wood Johnson Foundation
Color Genomics, Inc.
Salesforce
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis."

This proposal compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive.

For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines.

If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.


Condition Intervention
Breast Cancer Screening Breast Carcinoma in Situ Breast Cancer Other: Complete a health questionnaire Genetic: Provide a saliva sample for genetic testing Other: Screening advice based on a comprehensive risk assessment Other: Screening advice based on a basic risk assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Late-stage cancer [ Time Frame: 5 years ]
    Proportion of cancers diagnosed at Stage IIB or higher

  • Biopsy rate [ Time Frame: 5 years ]
    Rate of biopsies performed


Secondary Outcome Measures:
  • Late-stage cancers rate [ Time Frame: 5 years ]
    Rate of Stage IIB or higher cancers

  • Interval cancers rate [ Time Frame: 5 years ]
    Rate of interval (detected within 12-24 months of a normal screen) cancers

  • Rate of systemic therapy [ Time Frame: 5 years ]
    Rate of systemic therapy as measure of morbidity

  • Mammogram recall rate [ Time Frame: 5 years ]
    Mammogram recall rate as measure of morbidity

  • Breast biopsy rate [ Time Frame: 5 years ]
    Breast biopsy rate as measure of morbidity

  • DCIS rate [ Time Frame: 5 years ]
    Rate of ductal carcinoma in situ (DCIS) as a measure of morbidity, stratified by biologic type

  • Chemoprevention uptake rate [ Time Frame: 5 years ]
    Rate of uptake of endocrine prevention interventions

  • Choice of risk-based versus annual screening in self-assigned cohort [ Time Frame: 5 years ]
    Proportion of participants who choose risk-based versus annual screening in the self-assigned cohort as a measure of acceptability

  • Adherence to assigned screening schedule [ Time Frame: 5 years ]
    Proportion of participants who adhere to their assigned screening schedules as a measure of acceptability

  • Breast-cancer anxiety [ Time Frame: 5 years ]
    Breast cancer anxiety (as measured with the PROMIS anxiety scale) as a measure of acceptability

  • Decisional regret [ Time Frame: 5 years ]
    Decisional regret (as measured with the Decision Regret Scale, a 5-item Likert scale) as a measure of acceptability

  • Ultra-low risk cancer rate [ Time Frame: 5 years ]
    Rates of ultra-low risk cancer


Estimated Enrollment: 100000
Actual Study Start Date: August 31, 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Annual Arm
Women in this arm will receive Athena standard of care mammography screening, including annual mammograms. They will complete a health questionnaire and receive screening advice based on a basic risk assessment.
Other: Complete a health questionnaire
Complete a health history questionnaire.
Other: Screening advice based on a basic risk assessment
Receive a screening schedule recommendation
Experimental: Risk-Based Arm
Women in this arm will receive risk-based screening, where risk is calculated based on a model including personal history, family history, and genetic testing. All women in the risk-based arm complete a health questionnaire, provide a saliva sample for genetic testing, and receive screening advice based on a comprehensive risk assessment. Women in this arm will be tested for a panel of 9 genes related to breast cancer risk as well as a panel of SNPs, which can further modify risk. Women will be assigned a screening start date, screening stop date, and screening frequency.
Other: Complete a health questionnaire
Complete a health history questionnaire.
Genetic: Provide a saliva sample for genetic testing
Provide a saliva sample for testing of 9 genes and a panel of single nucleotide polymorphisms (SNPs) that influence breast cancer risk
Other: Screening advice based on a comprehensive risk assessment
Receive a screening schedule recommendation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Age 40 years old to 74 years old
  • Reside in California or receive care at a Sanford Health site

Exclusion Criteria:

  • Prior breast cancer or DCIS diagnosis
  • Non-English proficiency (plans to expand to Spanish by year 2)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620852


Contacts
Contact: Allison Fiscalini, MPH (415) 476-0267 allison.stoverfiscalini@ucsf.edu
Contact: Roxanna Firouzian, MPH (415) 476-8390 roxanna.firouzian@ucsf.edu

Locations
United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92618
Contact: Hannah Park, PhD    949-824-2651    hlpark@uci.edu   
Principal Investigator: Hoda Anton-Culver, PhD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Antonia Petruse, BA    310-794-0367    APetruse@mednet.ucla.edu   
Principal Investigator: Arash Naeim, MD, PhD         
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Skye Stewart, MS    916-734-5772    sdstewart@UCDavis.edu   
Principal Investigator: Alexander Borowsky, MD         
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Tracy Layton, BA    858-534-7984    tlayton@ucsd.edu   
Principal Investigator: Barbara Parker, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Irene Acerbi, PhD    415-476-0256    Irene.Acerbi@ucsf.edu   
Principal Investigator: Laura van 't Veer, PhD         
United States, South Dakota
Edith Sanford Breast Center Enrolling by invitation
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Robert Wood Johnson Foundation
Color Genomics, Inc.
Salesforce
Investigators
Principal Investigator: Laura Esserman, MD, MBA University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02620852     History of Changes
Other Study ID Numbers: PCS-1402-10749
First Submitted: December 1, 2015
First Posted: December 3, 2015
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by University of California, San Francisco:
Breast screening
mammography
prevention
risk assessment
DCIS
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type