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(Last updated: October 28, 2020)

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1

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: 3 or 5 visits, over 5 years

PHASE: III

NCT ID: NCT03233191

Breast Cancer Screening Based on Individual Risk Factors and Comparing the Effectiveness of 3D to 2D Mammography

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Scientific Title

Purpose
To study if risk-based screening for breast cancer is as safe and effective as age-based screening and if (3D) mammography is better than (2D) mammography at finding early-stage tumors.
Who is this for?
Women, age 45 to 74, who have never been diagnosed with DCIS or breast cancer. You must not have had a screening mammogram within the last 11 months    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Digital mammogram (2D)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Digital tomosynthesis mammogram (3D)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Most breast cancer screening guidelines are based upon a woman's age--not her individualized risk of developing breast cancer. </li> <li class="seamTextUnorderedListItem">For this trial, you will receive annual mammograms if you are premenopausal or postmenopausal with at least one risk factor.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 45-69: dense breasts, a first degree relative with breast cancer, an inherited genetic mutation that increases your risk of developing cancer, or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 70-74: dense breasts or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Digital tomosynthesis (3D) mammography is approved by the FDA but is not considered the standard of care for breast cancer screening.</li> <li class="seamTextUnorderedListItem">Digital (2D) mammography is the standard of care for breast cancer screening.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03233191' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/tmist' target='_blank'>ECOG-ACRIN Cancer Research Group Trial Information Page: TMIST</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/dig_tomosynth' target='_blank'>Breastcancer.org: Digital Tomosynthesis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/breast_center/treatments_services/breast_cancer_screening/digital_mammography/index.html' target='_blank'>Johns Hopkins Medicine: Digital Mammography</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/tmist-breast-cancer-screening' target='_blank'>NCI Cancer Currents Blog: TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches</a> </li></ul>
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2

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Online surveys

PHASE: NA

NCT ID: NCT02620852

WISDOM Study: Women Informed to Screen Depending on Measures of Risk

Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer Scientific Title

Purpose
To learn if risk-based breast screening is as safe and effective as annual mammogram screening for reducing risk and detecting breast cancer.
Who is this for?
Women between the ages of 40 and 70 who have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups, or you can choose your study group. </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Personalized, Risk-Based Screening</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendations based on comprehensive, personal risk assessment</li> <li class="seamTextUnorderedListItem">Saliva sample genetic test</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard Annual Screening</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendation for annual mammograms</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized risk-based screening will take multiple risk factors into consideration, including genetic markers, to determine how often you should have a mammogram.</li> <li class="seamTextUnorderedListItem">This study will help researchers learn if risk-based screening, which helps women learn more about their personal breast cancer risk, is less stressful and as successful at detecting breast cancer as annual screening. </li> <li class="seamTextUnorderedListItem">This study is available in English and Spanish.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02620852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thewisdomstudy.org/' target='_blank'>WISDOM: Study Information Page</a> </li></ul>
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3

NEAREST SITE: 2438 miles
Walter Reed Army Medical Center
Washington,DC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01322750

A Circulating Tumor Cell Test To Screen For Breast Cancer At Walter Reed National Military Medical Center

Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma Scientific Title

Purpose
To study if a blood test for circulating tumor cells (CTCs) can reliably find breast cancer before your cancer has become clinically detectable (seen on a mammogram, ultrasound, or other imaging).
Who is this for?
People without breast cancer and people with DCIS, stage I, stage II, or stage III breast cancer who are having a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) done at Walter Reed National Military Medical Center.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will have your blood drawn</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Scientists are researching new techniques to screen for breast cancer.</li> <li class="seamTextUnorderedListItem">Breast cancer cells can leave the tumor and move through the blood stream before the tumor is clinically detectable.</li> <li class="seamTextUnorderedListItem">Circulating tumor cell tests look for these traveling cancer cells and may provide a simple, reliable, and cost-effective form of breast cancer screening.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01322750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cbcp-research.org' target='_blank'>Walter Reed National Military Medical Center: Clinical Breast Care Project</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/blood_marker.jsp' target='_blank'>Breastcancer.org: Blood Marker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/types/breast/patient/breast-screening-pdq' target='_blank'>NCI: Breast Cancer Screening</a> </li></ul>
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