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Nők, akik a kockázat mértékétől függően szűrnek (Bölcsesség-tanulmány) (WISDOM)

2026. szeptember 17. frissítette: University of California, San Francisco

Paradigmaváltás engedélyezése: A személyre szabott, illetve az éves mellrákszűrés preferencia-toleráns RCT-je (Bölcsesség-tanulmány)

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 BReast CAncer gene (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 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.

Starting in Spring 2023, WISDOM's design shifted to remove the randomized option, but will continue with the preference/self-selection option for participation (WISDOM 2.0). Participants will therefore continue to choose their study arm (Personalized or Annual) rather than have the option to be randomized. This study design change was made after review of the WISDOM 1.0 data by an independent monitoring committee, which indicates that personalized screening does not cause harm. WISDOM 2.0 has also lowered the eligibility to ages 30-74. Women ages 30-39 will only be offered to join the Personalized Arm.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

For almost 30 years, annual mammograms for women over 40 have been a cornerstone of the US strategy to reduce mortality from breast cancer. A number of advances in the understanding of breast cancer biology, and screening in general, have led to calls to revise and improve national screening strategies (Esserman et al., 2014). In 2009, the US Preventive Services Task Force (USPSTF) introduced changes to screening guidelines, recommending that annual mammograms for all women 40-75 be replaced by biennial screening for women ages 50-75, and that screening in the 40's should be individualized by taking patient context into account, including the patient's values regarding specific benefits and harms. Despite being based on a thorough review of the scientific literature, these recommendations continue to spark debate and scientific opinion on the effectiveness of annual screening is greatly divided. On one hand the radiology and obstetrics/gynecology community argues that annual mammograms starting at 40 reduce the rate of interval cancers. On the other hand, primary care physicians and other specialists believe that annual screening results in more false-positives and unnecessary treatment and that a more targeted approach could result in fewer false-positives and less over-diagnosis without increasing the number of interval cancers. In fact it has been estimated that half of women will receive a false-positive recall over 10 years of annual screening and that as many as 20% of all breast cancers might be overdiagnosed. Since 2009 this debate has intensified, paralyzing the system and thwarting any efforts to change or improve screening. The end result is that women are frustrated and confused, and some have stopped screening altogether.

Despite a vastly improved understanding of breast cancer risk, the only criteria used to establish a woman's screening recommendations is her age (and BRCA status if known), but there are risk models available that incorporate personal and family history of breast disease, endocrine exposures and breast density to assess breast cancer risk (Constantino, et al., 1999; Parmigiani, et al., 1998; Tyrer, et al., 2004; Claus, et al., 2001; Ozanne, et al., 2003). Most recently certain genetic mutations and common genetic variants (single nucleotide polymorphisms or SNPs) have been confirmed predictors as well (Darabi, et al., 2012). Therefore, advances in this understanding of breast cancer biology, risk assessment, and imaging have enabled the creation of better tools and sufficient knowledge to replace the one-size-fits-all approach to screening and to implement a new, personalized model; one that provides recommendations on when to start, when to stop, and how often to screen that depend upon well characterized measures of risk.

The investigators propose to test a transformational evidence-based approach to breast screening that educates women about their actual risk, and tailors screening recommendations to them as individuals. Within the Athena Breast Health Network, the study will compare comprehensive, patient-centered risk-based screening to annual screening for women starting at age 40. The comprehensive risk assessment is based on a widely accepted risk model, the Breast Cancer Surveillance Consortium model, that includes endocrine exposures, family history and breast density, with additional genomic risk factors that include rare and uncommon major breast cancer susceptibility alleles as well as more common and recently validated single nucleotide polymorphisms (SNPs) that can, cumulatively, contribute significantly to a woman's individual risk. The study's personalized approach will recommend an age to start and stop screening as well as a frequency based upon individual risk. Women of highest risk will receive greater surveillance than those of lowest risk where the lower bound is the USPSTF recommended guidelines. In this manner, the study will focus the most effort on those most likely to develop the disease.

In close collaboration with patient advocates, the WISDOM 1.0 study has been designed as a 5-year, preference-tolerant, 65,000 patient, randomized controlled trial of risk-based versus annual screening. Individuals uncomfortable with the potential to be assigned to a particular arm in the randomized cohort can participate in the self-assigned observational cohort, an example of the pragmatic approach taken. Total accrual is anticipated to be 100,000 women across both cohorts. A broad group of stakeholders have participated in crafting this approach, including advocates, payers, the entire range of medical specialists and primary care providers and researchers involved with breast cancer screening across the entire Athena Network, technology partners, the Office of the President at the University of California, and policy-making organizations. WISDOM 1.0 trial was originally designed to randomize 65,000 women and be completed after five years to provide a median of ~3 years of exposure time in each randomized arm. However, due to slow initial accrual, trial duration was extended to up to ten years enabling a sample size reduction with maintained statistical power. The accrual goals were updated and approved by the Data Safety Monitoring Board (DSMB) and the Patient Centered Outcomes Research Institute.

The study hypothesizes that risk-based screening will be an improvement over annual screening because it will be as safe, less morbid, enable more cancer prevention, less stressful and more readily accepted by women as a result of an improved understanding of their personal risk.

The Athena Breast Health Network was established across the 5 University of California medical centers to develop a new, harmonized approach to breast cancer prevention, screening and treatment. Athena is among the few centers in North America to use technology to integrate risk assessment into breast screening. The investigators have developed a cadre of "breast health specialists" who provide women with counseling and support around risk and prevention. There are currently 100,000 registered Athena participants, with 30,000 new patients per year and growing with the addition of Sanford Health, one of the largest rural health networks in the country. The primary research mission of Athena is to address issues requiring a population-based approach and translate solutions to clinical practice. Athena is uniquely positioned to address the screening controversy and provide women with renewed confidence in decisions about their breast health. Risk-based screening for breast cancer is exactly the advanced, evidence-based approach to medicine described in the NIH and FDA's "Path to Personalized Medicine". If these hypotheses prove to be correct, this study will be able to establish a clear justification for its use, and provide a framework for widespread implementation that will benefit women across the country.

Starting in Spring 2023, WISDOM's design shifted to remove the randomized option, but will continue with the preference/self-selection option for participation (WISDOM 2.0). Participants will therefore continue to choose their study arm (Personalized or Annual) rather than have the option to be randomized. This study design change was made after review of the WISDOM 1.0 data by an independent monitoring committee, which indicates that personalized screening does not cause harm. WISDOM 2.0 has also lowered the eligibility to ages 30-74. Women ages 30-39 will only be offered to join the Personalized Arm.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

100000

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Egyesült Államok
    • Alabama
      • Birmingham, Alabama, Egyesült Államok, 35294
        • Toborzás
        • University of Alabama at Birmingham
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Rachael Lancaster, MD
    • California
      • Irvine, California, Egyesült Államok, 92618
        • Toborzás
        • University of California Irvine
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Hoda Anton-Culver, PhD
      • Los Angeles, California, Egyesült Államok, 90095
        • Toborzás
        • University of California Los Angeles
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Arash Naeim, MD, PhD
      • Sacramento, California, Egyesült Államok, 95817
        • Toborzás
        • University of California Davis
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Alexander Borowsky, MD
      • San Diego, California, Egyesült Államok, 92093
        • Toborzás
        • University of California San Diego
        • Alkutató:
          • Barbara Parker, MD
        • Alkutató:
          • Lisa Madlensky, PhD
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Sheri Hartman, PhD
      • San Francisco, California, Egyesült Államok, 94115
        • Toborzás
        • University of California San Francisco
        • Kutatásvezető:
          • Laura van 't Veer, PhD
        • Kapcsolatba lépni:
    • Florida
      • Miami, Florida, Egyesült Államok, 33173
        • Toborzás
        • TopLine MD Alliance
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Michael Plaza, MD
    • Illinois
      • Chicago, Illinois, Egyesült Államok, 60637
    • Louisiana
      • New Orleans, Louisiana, Egyesült Államok, 70112
        • Aktív, nem toborzó
        • Louisiana State University
    • New York
      • New York, New York, Egyesült Államok, 10021
        • Toborzás
        • Weill Cornell Medicine
        • Kutatásvezető:
          • Yiwey Shieh, MD
    • South Dakota
      • Sioux Falls, South Dakota, Egyesült Államok, 57117
        • Aktív, nem toborzó
        • Edith Sanford Breast Center

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

30 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Női

Leírás

Inclusion Criteria:

  1. Female*
  2. Age 30 years to 74 years old**
  3. Reside in the United States***

NOTE*: As of 2019, we are now enrolling all persons who identify as female, and will capture both their sex at birth and gender identity in the baseline survey.

NOTE**: Eligibility from 2016 - October 2023 included ages 40-74 (WISDOM 1.0) and expanded to age 30 in October 2023 (WISDOM 2.0).

NOTE***: As of 2019, recruitment is available nationwide. Original eligibility was limited to California, North Dakota, South Dakota, Iowa, Minnesota, Alabama, Louisiana, Illinois OR have coverage from a participating health plan.

Exclusion Criteria:

  1. Prior Breast cancer or ductal carcinoma in situ (DCIS) diagnosis
  2. Prior prophylactic bilateral mastectomy
  3. Inability to provide consent
  4. Non-English or Spanish proficiency (Spanish participation available: June 2019)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Szűrés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Aktív összehasonlító: 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.
Egyéb: Complete a health questionnaire

Complete a health history questionnaire.

Egyéb: Screening advice based on a basic risk assessment

Receive a screening schedule recommendation
Kísérleti: 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.
Egyéb: Complete a health questionnaire

Complete a health history questionnaire.

Eszköz: 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

Egyéb: Screening advice based on a comprehensive risk assessment

Receive a screening schedule recommendation

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Late-stage cancer
Időkeret: 5 years (minimum)

Proportion of cancers diagnosed at Stage IIB or higher
5 years (minimum)
Biopsy rate
Időkeret: 5 years (minimum)

Rate of biopsies performed
5 years (minimum)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Late-stage cancer rate and interval cancer rate
Időkeret: 5 years (minimum)

Rate of Stage IIB or higher cancers and rate of interval (detected within 12-24 months of a normal screen) cancers
5 years (minimum)
Rate of stage IIA cancers
Időkeret: 5 years (minimum)

To assess the difference between the arms in the rate of stage IIA cancers (prognostic and anatomic), specifically to test for non-inferiority of personalized screening compared with annual screening with respect to detection rates of prognostic and anatomic stage IIA cancers.
5 years (minimum)
Rate of systemic therapy
Időkeret: 5 years (minimum)

Rate of systemic therapy as measure of morbidity
5 years (minimum)
Breast imaging rate
Időkeret: 5 years (minimum)

Breast imaging (Mammogram or MRI) rate as measure of morbidity
5 years (minimum)
Breast biopsy rate
Időkeret: 5 years (minimum)

Breast biopsy rate as measure of morbidity
5 years (minimum)
DCIS rate
Időkeret: 5 years (minimum)

Rate of ductal carcinoma in situ (DCIS) as a measure of morbidity, stratified by biologic type
5 years (minimum)
Chemoprevention uptake rate
Időkeret: 5 years (minimum)

Rate of uptake of endocrine prevention interventions
5 years (minimum)
Choice of risk-based versus annual screening in self-assigned cohort
Időkeret: 5 years (minimum)

Proportion of participants who choose risk-based versus annual screening in the self-assigned cohort as a measure of acceptability
5 years (minimum)
Adherence to assigned screening schedule
Időkeret: 5 years (minimum)

Proportion of participants who adhere to their assigned screening schedules as a measure of acceptability
5 years (minimum)
Breast-cancer anxiety
Időkeret: 5 years (minimum)

Breast cancer anxiety (as measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale) as a measure of acceptability
5 years (minimum)
Decisional regret
Időkeret: 5 years (minimum)

Decisional regret (as measured with the Decision Regret Scale, a 5-item Likert scale) as a measure of acceptability
5 years (minimum)
Ultra-low risk cancer rate
Időkeret: 5 years (minimum)

Rates of ultra-low risk cancer
5 years (minimum)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of California, San Francisco

Együttműködők

Patient-Centered Outcomes Research Institute
National Cancer Institute (NCI)
United States Department of Defense
Robert Wood Johnson Foundation
Breast Cancer Research Foundation
Color Genomics, Inc.
Salesforce
Safeway Foundation

Nyomozók

  • Kutatásvezető: Laura Esserman, MD, MBA, University of California, San Francisco

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2016. augusztus 31.

Elsődleges befejezés (Becsült)

2029. szeptember 30.

A tanulmány befejezése (Becsült)

2029. szeptember 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2015. december 1.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2015. december 2.

Első közzététel (Becsült)

2015. december 3.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 21.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 17.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • PCS-1402-10749
  • NCI-2018-00562 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
  • R01CA237533-01A1 (Az Egyesült Államok NIH támogatása/szerződése)
  • 16752 (Egyéb azonosító: University of California, San Francisco)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Igen

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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