Trial Outcomes & Findings for Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue? (NCT NCT03207074)
NCT ID: NCT03207074
Last Updated: 2020-07-14
Results Overview
Sensitivity, specificity and positive and negative predictive values will be obtained for this new technology compared to gold standard (histopathological exam). Test sensitivity is the ability of the iknife to correctly identify those with endometrial cancer (true positive rate). Test specificity is the ability of the iKnife to correctly identify those without endometrial cancer (true negative rate). Positive predictive value is the probability that patients with a positive iKnife test result truly have the disease. Negative predictive value is the probability that patients with a negative screening iKnife test truly don't have endometrial cancer.
COMPLETED
NA
150 participants
Each patient was assessed in clinic and the research biopsy was performed during the clinic visit. It was processed within 4 hours by the iKnife (or snap frozen and processed at a later date, within 3months)
2020-07-14
Participant Flow
All patients attending rapid access clinic, or day surgery for investigation of suspected endometrial cancer were asked to participate in the study. Those needing tissue biopsies for clinical indications, were also asked to undergo a second research biopsy. The research biopsy is analysed by the iKnife.
Participant milestones
| Measure |
All Patients
Single study arm. All patients who participate in the study will receive a tissue biopsy, one processed with the conventional histology and one processed with the iKnife (Rapid Evaporative Ionisation Mass Spectrometry).
|
|---|---|
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Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Patients
n=150 Participants
Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife).
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.6 • n=150 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=150 Participants
|
|
Region of Enrollment
United Kingdom
|
150 participants
n=150 Participants
|
|
Body Mass Index (BMI)
|
30.7 kg/m^2
STANDARD_DEVIATION 8.4 • n=150 Participants
|
PRIMARY outcome
Timeframe: Each patient was assessed in clinic and the research biopsy was performed during the clinic visit. It was processed within 4 hours by the iKnife (or snap frozen and processed at a later date, within 3months)Population: Analysis of diagnostic accuracy of iKnife from endometrial pipelle biopsies
Sensitivity, specificity and positive and negative predictive values will be obtained for this new technology compared to gold standard (histopathological exam). Test sensitivity is the ability of the iknife to correctly identify those with endometrial cancer (true positive rate). Test specificity is the ability of the iKnife to correctly identify those without endometrial cancer (true negative rate). Positive predictive value is the probability that patients with a positive iKnife test result truly have the disease. Negative predictive value is the probability that patients with a negative screening iKnife test truly don't have endometrial cancer.
Outcome measures
| Measure |
All Patients
n=150 Participants
Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife)
|
|---|---|
|
Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens
Sensitivity
|
79 percentage
|
|
Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens
Specificity
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96 percentage
|
|
Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens
Positive Predictive value
|
93 percentage
|
|
Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens
Negative predictive value
|
86 percentage
|
Adverse Events
All Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place