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NCT02620852 · ClinicalTrials.gov registry record · NA

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

A NA study of Breast Cancer and Breast Cancer Screening, sponsored by University of California, San Francisco.

Recruiting
Registry status
NA
Development phase
100,000
Enrollment target
11
Study locations

NCT02620852 is a NA study of Breast Cancer and Breast Cancer Screening that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 100,000 participants, above the 2,722-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (3574% higher). The trial reports 11 study locations across 7 states.

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The verdict

NCT02620852, a NA study of Breast Cancer and Breast Cancer Screening, is actively recruiting participants, sponsored by University of California, San Francisco.

RECRUITING
Registry status
NA
Development phase
100,000 participants
Enrollment target
11
Study locations

Study Summary

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." The WISDOM 1.0 study 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

Interventions

  • OTHER Complete a health questionnaire
  • DEVICE 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 Locations (11)

California

  • University of California Irvine - Irvine
  • University of California Los Angeles - Los Angeles
  • University of California Davis - Sacramento
  • University of California San Diego - San Diego
  • University of California San Francisco - San Francisco

Alabama

  • University of Alabama at Birmingham - Birmingham

Florida

  • TopLine MD Alliance - Miami

Illinois

  • University of Chicago - Chicago

Louisiana

  • Louisiana State University - New Orleans

New York

  • Weill Cornell Medicine - New York

South Dakota

  • Edith Sanford Breast Center - Sioux Falls

Trial Details

FieldValue
Enrollment Target 100,000 participants
Start Date 2016-08-31
Est. Completion 2026-09-01
Phase NA

What the Registry Record Tells You About NCT02620852

The ClinicalTrials.gov registry entry for NCT02620852 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,722-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (3574% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Complete a health questionnaire is the first listed.

NCT02620852 reports 11 study locations spanning 7 distinct geographic areas - top geographies include California, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT02620852 about?

NCT02620852 is a clinical study titled "Women Informed to Screen Depending on Measures of Risk (Wisdom Study)". 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 whe...

What is the current status of trial NCT02620852?

This trial is currently recruiting. It is a NA study. The enrollment target is 100,000 participants. The study started on 2016-08-31. Estimated completion is 2026-09-01.

What conditions does trial NCT02620852 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Cancer Screening, Breast Carcinoma in Situ.

What interventions are being tested in trial NCT02620852?

The interventions under investigation include: Complete a health questionnaire (OTHER), Provide a saliva sample for genetic testing (DEVICE), Screening advice based on a comprehensive risk assessment (OTHER), Screening advice based on a basic risk assessment (OTHER).

Who is sponsoring clinical trial NCT02620852?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02620852 being conducted?

This trial has 11 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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