Trial Outcomes & Findings for Automated Method for Breast Cancer Detection (NCT NCT03863522)
NCT ID: NCT03863522
Last Updated: 2021-11-19
Results Overview
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.
TERMINATED
NA
116 participants
up to 2 years
2021-11-19
Participant Flow
Participant milestones
| Measure |
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).
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.
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.
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|---|---|
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Overall Study
STARTED
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116
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Overall Study
COMPLETED
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116
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Automated Method for Breast Cancer Detection
Baseline characteristics by cohort
| Measure |
Fine Needle Aspiration
n=116 Participants
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).
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.
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.
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|---|---|
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Age, Continuous
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48 years
n=5 Participants
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Sex: Female, Male
Female
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116 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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71 Participants
n=5 Participants
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Race (NIH/OMB)
White
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40 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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62 Participants
n=5 Participants
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Region of Enrollment
South Africa
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54 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to 2 yearsPopulation: Inadequate cell counts prevented analysis of samples. Data was not generated.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: Inadequate cell counts prevented analysis of samples. Data was not generated.
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Inadequate cell counts prevented analysis of samples. Data was not generated.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Inadequate cell counts prevented analysis of samples. Data was not generated.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Inadequate cell counts prevented analysis of samples. Data was not generated.
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
Outcome measures
Outcome data not reported
Adverse Events
Fine Needle Aspiration
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fine Needle Aspiration
n=62 participants at risk
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).
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.
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.
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Injury, poisoning and procedural complications
Bruising
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0.00%
0/62 • 2 weeks
The only intervention is FNA, which is immediately preceded by a core needle biopsy. Thus the cause, FNA vs core biopsy, of the AE will be impossible to determine. Via phone 1-2 days post-procedure and again 10-14 days post-procedure, patients were asked about any bruising and pain, but could report other symptoms if any. Please note only the 62 Johns Hopkins patients were called; the remaining 54 South African patients were not followed for AEs by this study team.
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Injury, poisoning and procedural complications
Pain
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4.8%
3/62 • Number of events 3 • 2 weeks
The only intervention is FNA, which is immediately preceded by a core needle biopsy. Thus the cause, FNA vs core biopsy, of the AE will be impossible to determine. Via phone 1-2 days post-procedure and again 10-14 days post-procedure, patients were asked about any bruising and pain, but could report other symptoms if any. Please note only the 62 Johns Hopkins patients were called; the remaining 54 South African patients were not followed for AEs by this study team.
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Injury, poisoning and procedural complications
Other
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0.00%
0/62 • 2 weeks
The only intervention is FNA, which is immediately preceded by a core needle biopsy. Thus the cause, FNA vs core biopsy, of the AE will be impossible to determine. Via phone 1-2 days post-procedure and again 10-14 days post-procedure, patients were asked about any bruising and pain, but could report other symptoms if any. Please note only the 62 Johns Hopkins patients were called; the remaining 54 South African patients were not followed for AEs by this study team.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place