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

NCT04510454 | Completed

• 1 other identifier: ONCOVID-21 - ET20-118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer; COVID

Keywords

COVID-19, SARS-CoV-2, ddPCR, cancer, serology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• To determine the RT-qPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection

  Third week after inclusion

• 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

  Third week after inclusion

• 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

  Third week after inclusion

• To determine the agreements between nasopharyngeal samples and oropharyngeal samples

  At inclusion

• To determine the agreements between a clinical diagnosis and ddPCR and RT-qPCR assays

  At inclusion

Other Outcomes (1)

• To evaluate the sensibility, specificity and diagnostic accuracy of "in-house" serologic test for the SARS-CoV-2 detection

  At inclusion

Study Arms (1)

RT-PCR and ddPCR sampling analyses

EXPERIMENTAL

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

Interventions

Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR DIAGNOSTIC_TEST

Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR

RT-PCR and ddPCR sampling analyses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bénédicte MASTROIANNI, MD

  Centre Léon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nasopharyngeal and oropharyngeal samples will be analyzed by the standard RT-qPCR test and the ddPCR assay.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: November 2, 2020
• Primary Completion: June 24, 2021
• Study Completion: October 12, 2021
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

FR (1)