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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

WISDOM Trial 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.Check my eligibility

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.See study design

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.

WISDOM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am a woman aged between 40 and 74.

WISDOM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biopsy rate

Late-stage cancer

Secondary outcome measures

Adherence to assigned screening schedule

Breast biopsy rate

Breast-cancer anxiety

+9 more

WISDOM 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,137,555 Total Patients Enrolled

45 Trials studying Breast Cancer

3,728,435 Patients Enrolled for Breast Cancer

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,896,948 Total Patients Enrolled

7 Trials studying Breast Cancer

1,398,793 Patients Enrolled for Breast Cancer

Robert Wood Johnson FoundationOTHER

157 Previous Clinical Trials

586,834 Total Patients Enrolled

1 Trials studying Breast Cancer

168 Patients Enrolled for Breast Cancer

Media Library

Risk-based Breast Cancer Screening Schedule (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02620852 — N/A

Breast Cancer Research Study Groups: Risk-Based Arm, Annual Arm

Breast Cancer Clinical Trial 2023: Risk-based Breast Cancer Screening Schedule Highlights & Side Effects. Trial Name: NCT02620852 — N/A

Risk-based Breast Cancer Screening Schedule (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02620852 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must an individual meet to be eligible for this experiment?

"This clinical trial is attempting to recruit 100000 people with breast cancer over 40 and below 74 years old. To qualify, participants must be female*, reside in one of the listed states or have health coverage from a specific plan**; additionally, due to available funds, recruitment will expand beyond this criteria if needed*. Participants' gender identity and sex assigned at birth are also required components of the baseline survey as of 2019."

Answered by AI

Are there numerous hospitals at which this experiment is being conducted?

"There are 10 clinical trial sites offering opportunities to participate in this study. This includes the University of California Los Angeles, Edith Sanford Breast Center, and University of California San Francisco; as well as 7 other medical centres."

Answered by AI

Does this clinical trial encompass individuals of more advanced age?

"As per this study's prerequisites, the lower age limit for enrollment is 40 years old and the upper cutoff point is 74."

Answered by AI

Is this experiment actively seeking participants?

"The research project, which was initially published on August 31st 2016 and most recently updated November 8th 2021 according to clinicaltrials.gov, is at present recruiting participants."

Answered by AI

What aims does this research endeavor seek to accomplish?

"Color Genomics Inc., the clinical trial sponsor, outlines that biopsy rate will be measured over 5 years as the primary outcome. Additionally, this research project aims to measure interval cancer rates (within 12-24 months of a normal screen), ultra-low risk cancer frequency and ductal carcinoma in situ incidence for stratified biologic types - as secondary outcomes."

Answered by AI

How extensive is the sample size of this clinical investigation?

"Affirmative. Clinicaltrials.gov displays that this clinical study, first posted on August 31st 2016 and recently reviewed on November 8th 2021, is currently recruiting patients. The trial requires 100000 participants to be enrolled at 10 sites across the nation."

Answered by AI