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Automated Method for Breast Cancer Detection

NCT ID: NCT03863522

Last Updated: 2021-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-07

Study Completion Date

2020-12-15

Brief Summary

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Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.

Detailed Description

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Conditions

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Breast Cancer Diagnosis

Keywords

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Breast Cancer Diagnosis Ultrasound-guided core needle biopsy Fine needle aspiration FNA Diagnostic Cartridge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fine Needle Aspiration

Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).

Group Type OTHER

Fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.

Cancer Detection cartridge

Intervention Type DEVICE

The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis.

Interventions

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Fine needle aspiration

Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.

Intervention Type PROCEDURE

Cancer Detection cartridge

The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis.

Intervention Type DEVICE

Other Intervention Names

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FNA

Eligibility Criteria

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Inclusion Criteria

* Patient must be female
* Patient must be 18 years of age or older
* Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

Exclusion Criteria

* Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Mullen, MD

Role: PRINCIPAL_INVESTIGATOR

JHU School of Medicine

Locations

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Johns Hopkins Hospital Outpatient Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Medical Imaging at Green spring Station

Lutherville-Timonium, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00172441

Identifier Type: OTHER

Identifier Source: secondary_id

J18138

Identifier Type: -

Identifier Source: org_study_id