Clinical trial · Observational
COVID-19 Detection Test in Oncology
COVID-19 Serodiagnosis in Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Non immune patient
- description
- Patients with a negative SARS-CoV-2 immunoassay
- label
- Immune patient
- description
- Patients with a positive SARS-CoV-2 immunoassay
Primary outcomes (1)
- measure
- To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months.
- timeFrame
- 3 months
- description
- The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥18 years old 2. Patient diagnosed with invasive cancer (solid tumor only) 3. Patient in active phase of cancer treatment (surgery, chemotherapy, radiotherapy, immunotherapy or targeted therapy ongoing or planned within the next month- excepted patient treated by hormonotherapy and targeted therapy alone in adjuvant setting) 4. Patient with a local immunoassay realized before inclusion realized during the standard practice with a positive or negative result (test name and reference should be available) 5. Information and non-opposition of the patient to the study procedure Exclusion Criteria: 1. Person deprived of their liberty or under protective custody or guardianship 2. Patients unwilling or unable to comply with the medical follow-up required by the study because of geographic, familial, social, or psychological reasons 3. Patients treated for a hematological malignancy 4. Life expectancy \<6 months
References
Publications (0)
Data not yet available