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Behavioural Intervention

Risk-Based Screening for Breast Cancer (WISDOM Trial)

N/A

Recruiting

Led By Laura Esserman, MD, MBA

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female aged 40 to 74 years old

Be older than 18 years old

Must not have

Prior prophylactic bilateral mastectomy

Inability to provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing annual breast cancer screening to a risk-based breast cancer screening schedule. The goal is to see if the risk-based schedule detects breast cancers earlier and causes fewer false positives.

Who is the study for?

This trial is for women aged 40 to 74 who understand English or Spanish. It's open nationwide in the US and includes those who identify as female, capturing both sex at birth and gender identity. Women with a history of breast cancer, DCIS, or bilateral mastectomy can't join.

What is being tested?

The study tests personalized breast cancer screening schedules based on individual risk against traditional annual screenings. Participants provide saliva for genetic testing, complete health questionnaires, and receive screening advice tailored to their comprehensive or basic risk assessment.

What are the potential side effects?

There are no direct side effects from participating in this study since it involves non-invasive procedures like providing a saliva sample and receiving different types of screening advice rather than medical treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 40 and 74.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had both breasts removed to prevent cancer.

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I am unable to give consent by myself.

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I have been diagnosed with breast cancer or DCIS before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biopsy rate

Late-stage cancer

Secondary study objectives

Adherence to assigned screening schedule

Breast biopsy rate

Breast-cancer anxiety

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Risk-Based ArmExperimental Treatment3 Interventions

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.

Group II: Annual ArmActive Control2 Interventions

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.

0 / 4Eligibility criteria met