Trial Outcomes & Findings for COVID-19 Infection Screening in Cancer Patients (NEOSCREENCOVID) (NCT NCT04492410)
NCT ID: NCT04492410
Last Updated: 2026-07-02
Results Overview
Results for IgG testing. The number of samples may exceed the number of participants as re-testing was allowed.
COMPLETED
NA
214 participants
Baseline (Day 0)
2026-07-02
Participant Flow
Participant milestones
| Measure |
Experimental Arm
screening using a rapid serological test with a drop of blood from a finger prick.
|
|---|---|
|
Overall Study
STARTED
|
214
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Experimental Arm
screening using a rapid serological test with a drop of blood from a finger prick.
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Death
|
19
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Missed visit window / Not seen within protocol-defined timeframe
|
23
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=211 Participants
screening using a rapid serological test with a drop of blood from a finger prick.
|
|---|---|
|
Age, Continuous
|
64.81 years
STANDARD_DEVIATION 12.68 • n=211 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=211 Participants
|
|
Presence of COVID-19 Symptoms
No
|
190 Participants
n=210 Participants • Missing data for 1 participant
|
|
Presence of COVID-19 Symptoms
Yes
|
20 Participants
n=210 Participants • Missing data for 1 participant
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: The analysis population includes all participants who met the study eligibility criteria. Of the 214 participants enrolled, 3 were excluded from the analysis set because they were found to be ineligible (inclusion errors) after enrollment. The number of tests exceeds the number of participants because re-testing was permitted per protocol if the initial sample was inconclusive or for clinical monitoring. All valid test results obtained within the specified time frame are reported.
Results for IgG testing. The number of samples may exceed the number of participants as re-testing was allowed.
Outcome measures
| Measure |
Experimental Arm
n=223 Numbers of tests
screening using a rapid serological test with a drop of blood from a finger prick.
|
Healthcare Professionals
Healthcare professionals (physicians, nurses, or laboratory technicians) involved in the COVID-19 screening process who completed the satisfaction/feedback survey regarding the testing techniques.
|
|---|---|---|
|
Number of IgG Test Results at Inclusion
Positive (Samples)
|
21 Numbers of tests
|
—
|
|
Number of IgG Test Results at Inclusion
Equivocal Positive (Samples)
|
41 Numbers of tests
|
—
|
|
Number of IgG Test Results at Inclusion
Negative (Samples)
|
153 Numbers of tests
|
—
|
|
Number of IgG Test Results at Inclusion
Equivocal Negative (Samples)
|
2 Numbers of tests
|
—
|
|
Number of IgG Test Results at Inclusion
Non-contributory (Samples)
|
4 Numbers of tests
|
—
|
|
Number of IgG Test Results at Inclusion
Result not available
|
2 Numbers of tests
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: The analysis population includes all participants who met the study eligibility criteria. Of the 214 participants enrolled, 3 were excluded from the analysis set because they were found to be ineligible (inclusion errors) after enrollment. The number of tests exceeds the number of participants because re-testing was permitted per protocol if the initial sample was inconclusive or for clinical monitoring. All valid test results obtained within the specified time frame are reported.
Results for IgM testing. The number of samples may exceed the number of participants as re-testing was allowed.
Outcome measures
| Measure |
Experimental Arm
n=218 Numbers of tests
screening using a rapid serological test with a drop of blood from a finger prick.
|
Healthcare Professionals
Healthcare professionals (physicians, nurses, or laboratory technicians) involved in the COVID-19 screening process who completed the satisfaction/feedback survey regarding the testing techniques.
|
|---|---|---|
|
Number of IgM Test Results at Inclusion
Positive (Samples)
|
24 Tests
|
—
|
|
Number of IgM Test Results at Inclusion
Equivocal Positive (Samples)
|
54 Tests
|
—
|
|
Number of IgM Test Results at Inclusion
Negative (Samples)
|
135 Tests
|
—
|
|
Number of IgM Test Results at Inclusion
Equivocal Negative (Samples)
|
1 Tests
|
—
|
|
Number of IgM Test Results at Inclusion
Non-contributory (Samples)
|
4 Tests
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis population includes all participants available at this time point (N=211). The total number of responses in the categories may be lower than the overall number of participants analyzed due to missing data or incomplete questionnaires for some variables (e.g., participants who declined to answer specific questions).
The assessment of the perception of the rapid serological test for patient and health care professional will be measured in terms of Pain, simplicity, rapidity and satisfaction, reported on a questionnaire: * • Pain: The pain assessment will be performed using a visual analog scale (VAS). The score will be graded between 0 (absence of pain) to 10 (maximum pain) * • Simplicity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". * • Rapidity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". * • Satisfaction with care: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good"
Outcome measures
| Measure |
Experimental Arm
n=211 Participants
screening using a rapid serological test with a drop of blood from a finger prick.
|
Healthcare Professionals
n=45 Participants
Healthcare professionals (physicians, nurses, or laboratory technicians) involved in the COVID-19 screening process who completed the satisfaction/feedback survey regarding the testing techniques.
|
|---|---|---|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Speed · Not at All Satisfied
|
1 Participants
|
0 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Speed · Not available
|
3 Participants
|
0 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Simplicity · Slightly Satisfied
|
3 Participants
|
1 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Simplicity · Not at All Satisfied
|
0 Participants
|
0 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Simplicity · Not available
|
5 Participants
|
0 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Speed · Very Satisfied
|
188 Participants
|
35 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Speed · Somewhat Satisfied
|
16 Participants
|
10 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Speed · Slightly Satisfied
|
3 Participants
|
0 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Simplicity · Very Satisfied
|
189 Participants
|
35 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
Simplicity · Somewhat Satisfied
|
14 Participants
|
9 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
SATISFACTION · Very Satisfied
|
187 Participants
|
9 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
SATISFACTION · Somewhat Satisfied
|
14 Participants
|
15 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
SATISFACTION · Slightly Satisfied
|
6 Participants
|
14 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
SATISFACTION · Not at All Satisfied
|
1 Participants
|
6 Participants
|
|
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
SATISFACTION · Not available
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis population includes all participants who met the study eligibility criteria. Of the 214 participants enrolled, 3 were excluded from the analysis set because they were found to be ineligible (inclusion errors) after enrollment. The number of tests exceeds the number of participants because re-testing was permitted per protocol if the initial sample was inconclusive or for clinical monitoring. All valid test results obtained within the specified time frame are reported.
Results for RT-PCR testing. The number of samples may exceed the number of participants as re-testing was allowed.
Outcome measures
| Measure |
Experimental Arm
n=66 Number of RT-PCR Test Results at Inclusi
screening using a rapid serological test with a drop of blood from a finger prick.
|
Healthcare Professionals
Healthcare professionals (physicians, nurses, or laboratory technicians) involved in the COVID-19 screening process who completed the satisfaction/feedback survey regarding the testing techniques.
|
|---|---|---|
|
Number of RT-PCR Test Results at Inclusion
Negative
|
59 Number of RT-PCR Test Results at Inclusi
|
—
|
|
Number of RT-PCR Test Results at Inclusion
Positive
|
7 Number of RT-PCR Test Results at Inclusi
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis population includes all participants available at this time point (N=211). The total number of responses in the categories may be lower than the overall number of participants analyzed due to missing data or incomplete questionnaires for some variables (e.g., participants who declined to answer specific questions).
The assessment of the perception of the rapid serological test for patient will be measured in terms of Pain, simplicity, rapidity and satisfaction, reported on a questionnaire: * • Pain: The pain assessment will be performed using a visual analog scale (VAS). The score will be graded between 0 (absence of pain) to 10 (maximum pain) * • Simplicity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". * • Rapidity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". * • Satisfaction with care: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good"
Outcome measures
| Measure |
Experimental Arm
n=211 Participants
screening using a rapid serological test with a drop of blood from a finger prick.
|
Healthcare Professionals
Healthcare professionals (physicians, nurses, or laboratory technicians) involved in the COVID-19 screening process who completed the satisfaction/feedback survey regarding the testing techniques.
|
|---|---|---|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
0
|
163 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
2
|
14 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
1
|
19 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
3
|
5 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
4
|
3 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
5
|
3 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
6
|
1 Participants
|
—
|
|
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
Not available
|
3 Participants
|
—
|
Adverse Events
Experimental Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Centre Antoine Lacassagne
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place