Breast Cancer DiagnosisNCT03863522
Automated Method for Breast Cancer Detection
A study testing Fine needle aspiration and Cancer Detection cartridge in people with Breast Cancer Diagnosis, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Diagnosis
- What is being tested?
- Fine needle aspiration and Cancer Detection cartridge
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, 21287
Johns Hopkins Medical Imaging at Green spring Station
Lutherville-Timonium, Maryland, 21093
About this study
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.
- Conditions
- Breast Cancer Diagnosis
- Being tested
- Fine needle aspiration, Cancer Detection cartridge
- Keywords
- Breast Cancer Diagnosis, Ultrasound-guided core needle biopsy, Fine needle aspiration, FNA, Diagnostic Cartridge
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle aspirationProcedure or surgery
Also called FNA
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 cartridgeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fine Needle Aspiration | Other | 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). Receives: Procedure: Fine needle aspiration; Device: Cancer Detection cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.
Measured: up to 2 years
Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
Measured: up to 2 years
Secondary outcomes (3)
Correlation of Diagnostic Cartridge With Known Lab Assay
Number of participants in whom gene-methylation prediction of FNA in the Cancer Detection cartridge is malignant or benign when compared to gene-methylation prediction of FNA using our known laboratory assay (QM-MSP)
Measured: up to 2 years
Correlation of Known Lab Assay for FNA Versus the Core Biopsy
Number of participants in whom gene-methylation prediction of benign or malignant using our known laboratory assay (QM-MSP) matches for both the FNA sample and the core biopsy sample
Measured: up to 2 years
Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections
Number of participants with same expression of ER/PR/Her2 and Ki67 in FNAs of methylation positive breast lesions as with expression of ER/PR/Her2 and Ki67 in Formalin-Fixed Paraffin-Embedded (FFPE) sections of tumors using cartridge based quantitative evaluation
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start7 Mar 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Why it stopped: Inadequate FNA samples (low cell counts)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Mullen, MD, Principal investigator, JHU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863522
- Sponsor's protocol ID
- J18138
- Other IDs
- IRB00172441
- Status last verified
- Oct 2021
- First submitted
- 4 Mar 2019
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Method for Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT03863522
- Acronym / sponsor ID
- J18138
- Conditions
- Breast Cancer Diagnosis
- Keywords
- Breast Cancer Diagnosis, Ultrasound-guided core needle biopsy, Fine needle aspiration, FNA, Diagnostic Cartridge
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate FNA samples (low cell counts)
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fine Needle Aspiration | Other | Procedure: Fine needle aspiration, Device: Cancer Detection cartridgeParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine needle aspirationAlso: FNAFine 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. | Procedure or surgery | Fine Needle Aspiration |
| Cancer Detection cartridgeThe 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. | Device | Fine Needle Aspiration |
Primary outcome
Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
Time frame: up to 2 years
Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.
Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
Time frame: up to 2 years
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
3 secondary outcomes
Correlation of Diagnostic Cartridge With Known Lab Assay
Time frame: up to 2 years
Correlation of Known Lab Assay for FNA Versus the Core Biopsy
Time frame: up to 2 years
Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Mullen, MD principal investigator
JHU School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine needle aspiration and Cancer Detection cartridge in people with Breast Cancer Diagnosis, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.