An interventional study of rapid serological test in Cancer, sponsored by Centre Antoine Lacassagne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Screening
Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients.
The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 214 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Centre Antoine Lacassagne is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
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6. Patient affiliated with a health insurance system.
Exclusion Criteria:
Vulnerable persons as defined by article L1121-5 - 8:
screening using a rapid serological test with a drop of blood from a finger prick.
Other: rapid serological test
screening using a rapid serological test with a drop of blood from a finger prick
Number of IgG Test Results at Inclusion
Results for IgG testing. The number of samples may exceed the number of participants as re-testing was allowed.
Time frame: Baseline (Day 0)
Number of IgM Test Results at Inclusion
Results for IgM testing. The number of samples may exceed the number of participants as re-testing was allowed.
Time frame: Baseline (Day 0)
To Evaluate Patient's and Health Care Professional's Perception About the Rapid Serological Test.
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"
Time frame: Day 1
Number of RT-PCR Test Results at Inclusion
Results for RT-PCR testing. The number of samples may exceed the number of participants as re-testing was allowed.
Time frame: Day 1
To Evaluate Patient's Pain Perception About the Rapid Serological Test.
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"
Time frame: Day 1
| Milestone | Experimental Arm |
|---|---|
| Started | 214 |
| Completed | 154 |
| Not completed | 60 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Death | 19 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 12 |
| Withdrew: Missed visit window / not seen within protocol-defined timeframe | 23 |
Results for IgG testing. The number of samples may exceed the number of participants as re-testing was allowed.
| Numbers of tests | Experimental Arm |
|---|---|
| Positive (Samples) | 21 |
| Equivocal Positive (Samples) | 41 |
| Negative (Samples) | 153 |
| Equivocal Negative (Samples) | 2 |
| Non-contributory (Samples) | 4 |
| Result not available | 2 |
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"
| Participants | Experimental Arm | Healthcare Professionals |
|---|---|---|
| Speed — Very Satisfied | 188 | 35 |
| Speed — Somewhat Satisfied | 16 | 10 |
| Speed — Slightly Satisfied | 3 | 0 |
| Speed — Not at All Satisfied | 1 | 0 |
| Speed — Not available | 3 | 0 |
| Simplicity — Very Satisfied | 189 | 35 |
| Simplicity — Somewhat Satisfied | 14 | 9 |
| Simplicity — Slightly Satisfied | 3 | 1 |
| Simplicity — Not at All Satisfied | 0 | 0 |
| Simplicity — Not available | 5 | 0 |
| SATISFACTION — Very Satisfied | 187 | 9 |
| SATISFACTION — Somewhat Satisfied | 14 | 15 |
| SATISFACTION — Slightly Satisfied | 6 | 14 |
| SATISFACTION — Not at All Satisfied | 1 | 6 |
| SATISFACTION — Not available | 3 | 0 |
Results for RT-PCR testing. The number of samples may exceed the number of participants as re-testing was allowed.
| Number of RT-PCR Test Results at Inclusi | Experimental Arm |
|---|---|
| Negative | 59 |
| Positive | 7 |
Results for IgM testing. The number of samples may exceed the number of participants as re-testing was allowed.
| Tests | Experimental Arm |
|---|---|
| Positive (Samples) | 24 |
| Equivocal Positive (Samples) | 54 |
| Negative (Samples) | 135 |
| Equivocal Negative (Samples) | 1 |
| Non-contributory (Samples) | 4 |
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"
| Participants | Experimental Arm |
|---|---|
| 0 | 163 |
| 1 | 19 |
| 2 | 14 |
| 3 | 5 |
| 4 | 3 |
| 5 | 3 |
| 6 | 1 |
| Not available | 3 |
Collected over from enrollment until end of follow-up, up to 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Arm | 19/211 (9%) | 0/211 (0%) | 0/211 (0%) |
| Age, Continuous(years) | Experimental Arm |
|---|---|
| Mean | 64.81 ± 12.68 |
| Sex: Female, Male(Participants) | Experimental Arm |
|---|---|
| Female | 117 |
| Male | 94 |
| Race and Ethnicity Not Collected(Participants) | Experimental Arm |
|---|
| Presence of COVID-19 Symptoms(Participants) | Experimental Arm |
|---|---|
| No | 190 |
| Yes | 20 |
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Plan to share: No
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Centre Antoine Lacassagne