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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COMPLETED
NA
2 participants
INTERVENTIONAL
2020-12-10
2024-01-01
Brief Summary
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Detailed Description
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I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
OUTLINE:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
After completion of study, participants are followed up at 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (nipple aspiration fluid)
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
Aspiration of Breast
Undergo NAF
Biospecimen Collection
Undergo NAF
Interventions
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Aspiration of Breast
Undergo NAF
Biospecimen Collection
Undergo NAF
Eligibility Criteria
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Inclusion Criteria
* BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
* BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
* BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
* HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
* HEALTHY SUBJECTS: Must be \> 1 year from pregnancy, lactation.
* HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.
* HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health status for 1 year.
Exclusion Criteria
* Subjects who currently are diagnosed with cancers other than breast cancer.
* Subjects who cannot give an informed consent.
* Male gender of any age.
40 Years
FEMALE
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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William Carson
Principal Investigator
Principal Investigators
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William Carson, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2018-01437
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16288
Identifier Type: -
Identifier Source: org_study_id
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