Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

Cancer Clinical Trial

— ONCOVID-21  

Official title:

Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510454
• Other study ID #: ONCOVID-21 - ET20-118
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: December 2022
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).

Description:

The Bio-Rad SARS-CoV-2 ddPCR Test is a reverse transcription (RT) droplet digital polymerase chain reaction (ddPCR) test designed to detect RNA from SARS-CoV-2 in specimens (mainly nasopharyngeal, anterior nasal, oropharyngeal and mid-turbinate swab but also nasopharyngeal wash/aspirate and nasal aspirate specimens) collected from individuals who are suspected of COVID-19 infection.

This single assay multiplex test enables a one-well reaction with three sets of the oligonucleotide primers and probes which were reported by CDC. Two were selected from regions of the virus nucleocapsid (N) gene. An additional primer/probe included in the panel is set to detect the human RNase P gene (RP) in control samples and clinical specimens.

RNA isolated and purified from swab specimens is added to the mastermix comprised of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad One-Step RT-ddPCR Advanced Kit for Probes.

Briefly, the sample and mastermix RT-ddPCR mixtures are fractionated into up to 20,000 nanoliter-sized droplets in the form of a water-in-oil emulsion. The 96-well RT-ddPCR ready plate containing droplets is sealed with foil using a plate sealer. The emulsions are then thermocycled to achieve reverse transcription to generate cDNA followed by target amplification plus probe hydrolysis in each droplet. After thermocycling is complete, the 96-well RT-ddPCR ready plate is loaded into the Droplet Reader. The Droplet Reader singulates the droplets and flows them past a two-color fluorescence detector (FAM and HEX) in order to determine which contain target (positive) and which do not (negative) for each of the targets identified with the SARS-CoV-2 ddPCR Test: N1, N2 and RP. The ddPCR system uses the QuantaSoft 1.7 and QuantaSoft Analysis Pro 1.0 for analysis software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 12, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Age = 18 years on the day of signing informed consent.

2. Confirmed diagnosis of any type of solid or hematologic tumor.

3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure).

4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion.

5. Covered by a medical/health insurance.

6. Signed and dated IRB/ICE approved informed consent form.

Related Conditions & MeSH terms

• Cancer
• COVID
• COVID-19

Intervention

Diagnostic Test:
• Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR
Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the sensibility, specificity and diagnostic accuracy of "in-house" serologic test for the SARS-CoV-2 detection	Comparison of our "in-house" test to the commercial serology test from EUROIMMUN used for the study	At inclusion
Primary	To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection	Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test)	At inclusion
Secondary	To determine the RT-qPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection	Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard	Third week after inclusion
Secondary	To determine the ddPCR and RT-qPCR abilities to detect the SARS-CoV-2 in oropharyngeal samples of symptomatic patients with suspected COVID-19 infection	Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard	Third week after inclusion
Secondary	To determine the ability of a clinical diagnosis based both on patients' symptoms and chest CT-scan to detect the SARS-CoV-2 in symptomatic patients with suspected COVID-19 infection	Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard	Third week after inclusion
Secondary	To determine the agreements between nasopharyngeal samples and oropharyngeal samples	Using ddPCR and RT-qPCR assays	At inclusion
Secondary	To determine the agreements between a clinical diagnosis and ddPCR and RT-qPCR assays	Using ddPCR and RT-qPCR assays	At inclusion
Secondary	To assess the 28-day mortality rate	Rate calculated from the date of the first diagnostic procedure to the date of death of any cause	Up to the follow-up end (28 days after inclusion)
Secondary	To determine potential predictive factors of death among patients' characteristics	Demographics, type of tumor, type of anticancer, treatment, comorbidities, biological parameters	Up to the follow-up end (28 days after inclusion)
Secondary	To evaluate the over risk of death of patients COVID+ versus COVID-	After adjusting on main clinical characteristics and treatment type	Up to the follow-up end (28 days after inclusion)