- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04427280
Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19) (CARDS)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Patients with cancer are thought to have a weakened immune system and small observational case series have suggested patients with cancer are at a higher risk of poor outcome from COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not known. In addition, it is unclear when it is appropriate for cancer patients who have recovered from COVID-19 infection to resume anti-cancer therapy.
There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly determine whether the virus has been cleared of the COVID-19. Lateral flow assays investigated in this study are rapid and simple diagnostic tools which can assist in timely diagnostics to inform clinical decision making.
This observational study aims to describe the immunological dynamics and clinical course of COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays.
The information from our study will add significantly to the understanding of COVID-19 diagnostics and will improve the evidence-base for the management of cancer patients. Furthermore, data from this study could inform the timing and treatment for cancer patients who have recovered from COVID-19 infection.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Surrey
-
Sutton, Surrey, Storbritannia, SM2 5PT
- The Royal Marden NHS Foundation Trust
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Arm A
Suspected acute COVID-19 infection
|
Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection.
Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56.
Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected.
Saliva will be tested by the lateral flow assay when available and excess material stored.
Approximately 30mL of blood will be taken at each study visit.
|
Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
|
Approximately 30mL of blood will be taken at each study visit.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.
Tidsramme: 56 days
|
56 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinical course of SARS-CoV-2 infection in cancer patients.
Tidsramme: 56 days
|
Duration of clinical symptoms
|
56 days
|
Clinical course of SARS-CoV-2 infection in cancer patients.
Tidsramme: 56 days
|
Severity of clinical symptoms
|
56 days
|
Clinical course of SARS-CoV-2 infection in cancer patients.
Tidsramme: 56 days
|
Number of patients whose cancer treatment has been impacted by SARS-CoV-2
|
56 days
|
Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.
Tidsramme: 56 days
|
56 days
|
|
Time from start of symptoms to Day 0 testing in the study.
Tidsramme: 56 days
|
56 days
|
|
Feasibility of SARS-CoV-2 testing with a lateral flow assay.
Tidsramme: 56 days
|
|
56 days
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sheela Rao, MD FRCP, Royal Marsden NHS Foundation Trust
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CCR 5287
- 20/NE/0139 (Annen identifikator: Research Ethics Committee)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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