Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
NCT ID: NCT06060561
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
500 participants
OBSERVATIONAL
2023-05-30
2028-06-30
Brief Summary
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Detailed Description
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I. To collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) (and related single nucleotide polymorphisms \[SNPs\]) to final diagnosis of ductal carcinoma in situ (DCIS), invasive breast cancer or benign breast disease (BBD); BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise.
II. To relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries.
III. To relate PRS (and related SNPs) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (BC) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[HER2\] overexpressing) and biomarkers in BBD and lobules.
OUTLINE: This is an observational study.
Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Observational
Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Referred for a radiologically guided breast biopsy
Exclusion Criteria
* Women under the age of 18 years
* Unable to provide informed consent
18 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Mark E. Sherman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-06044
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-011193
Identifier Type: OTHER
Identifier Source: secondary_id
22-011193
Identifier Type: -
Identifier Source: org_study_id
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