Clinical trial · Observational
Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
NCT04427280CI-TRIAL-00094490CARDScompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Coronavirus Infection | — | UNRESOLVED | — |
| Infectious Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Diagnostic Test | — | UNRESOLVED |
| Saliva collection | Diagnostic Test | — | UNRESOLVED |
| Throat/nose swabs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm A
- description
- Suspected acute COVID-19 infection
- interventionNames
- Diagnostic Test: Throat/nose swabs
- Diagnostic Test: Saliva collection
- Diagnostic Test: Blood collection
- label
- Arm B
- description
- Asymptomatic patients with no clinical suspicion of COVID-19
- interventionNames
- Diagnostic Test: Blood collection
Primary outcomes (4)
- measure
- Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
- timeFrame
- Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) * Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid organ malignancy having received therapy (radiotherapy, chemotherapy or targeted agents) * Patient is ≥ 18 years of age. * Patient can understand the patient information sheet and is able to provide written informed consent. Exclusion Criteria: * There are no exclusion criteria for this study.
References
Publications (1)
- DERIVEDLau DK, Aresu M, Planche T, Tran A, Lazaro-Alcausi R, Duncan J, Kidd S, Cromarty S, Begum R, Rana I, Li S, Suwaidan AA, Monahan I, Clark DJ, Eckersley N, Staines HM, Groppelli E, Krishna S, Mayora-Neto M, Temperton N, Fribbens C, Watkins D, Starling N, Chau I, Cunningham D, Rao S. SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy. Oncologist. 2023 Jan 18;28(1):e1-e8. doi: 10.1093/oncolo/oyac230. PMID 36342104