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Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19 (ONCOVID-21)

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ClinicalTrials.gov Identifier: NCT04510454
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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).

Condition or disease Intervention/treatment Phase
Cancer COVID Diagnostic Test: Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Nasopharyngeal and oropharyngeal samples will be analyzed by the standard RT-qPCR test and the ddPCR assay.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: RT-PCR and ddPCR sampling analyses
Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR
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




Primary Outcome Measures :
  1. To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection [ Time Frame: At inclusion ]
    Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test)


Secondary Outcome Measures :
  1. To determine the RT-qPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection [ Time Frame: Third week after inclusion ]
    Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard

  2. 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 [ Time Frame: Third week after inclusion ]
    Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard

  3. 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 [ Time Frame: Third week after inclusion ]
    Using IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard

  4. To determine the agreements between nasopharyngeal samples and oropharyngeal samples [ Time Frame: At inclusion ]
    Using ddPCR and RT-qPCR assays

  5. To determine the agreements between a clinical diagnosis and ddPCR and RT-qPCR assays [ Time Frame: At inclusion ]
    Using ddPCR and RT-qPCR assays

  6. To assess the 28-day mortality rate [ Time Frame: Up to the follow-up end (28 days after inclusion) ]
    Rate calculated from the date of the first diagnostic procedure to the date of death of any cause

  7. To determine potential predictive factors of death among patients' characteristics [ Time Frame: Up to the follow-up end (28 days after inclusion) ]
    Demographics, type of tumor, type of anticancer, treatment, comorbidities, biological parameters

  8. To evaluate the over risk of death of patients COVID+ versus COVID- [ Time Frame: Up to the follow-up end (28 days after inclusion) ]
    After adjusting on main clinical characteristics and treatment type


Other Outcome Measures:
  1. To evaluate the sensibility, specificity and diagnostic accuracy of "in-house" serologic test for the SARS-CoV-2 detection [ Time Frame: At inclusion ]
    Comparison of our "in-house" test to the commercial serology test from EUROIMMUN used for the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510454


Contacts
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Contact: Ellen BLANC 04.78.78.29.67 ellen.blanc@lyon.unicancer.fr
Contact: Bénédicte MASTROIANNI, MD benedicte.mastroianni@lyon.unicancer.fr

Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Bénédicte MASTROIANNI, MD Centre Léon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04510454    
Other Study ID Numbers: ONCOVID-21 - ET20-118
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
COVID-19, SARS-CoV-2, ddPCR, cancer, serology