COVID-19 Detection Test in Oncology

NCT04367870 | Completed

• 2 other identifiers: UC-TRA-20022020-A01002-37
• Study Type: observational
• Target: 441
• Locations: 1 country
• Sites: 7

Brief Summary

EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.

Conditions

Oncology

Keywords

Cancer; SARS-CoV-2; COVID-19; coronavirus; serodiagnosis; immunoassay

Outcome Measures

Primary Outcomes (1)

• To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months.

  The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.

  3 months

Secondary Outcomes (3)

• To estimate the discordance rate between local immunoassay and a centralized ELISA in patients with a positive immunoassay, whatever the immunoassay.

  6 months

• To identify patients with very low risk of recurrence of COVID-19 within 6 months following a positive immunoassay result.

  6 months

• To characterize the evolution over time of the serologic response against SARS-CoV-2 (in a subgroup of patients).

  6 months

Study Arms (2)

Non immune patient

Patients with a negative SARS-CoV-2 immunoassay

Immune patient

Patients with a positive SARS-CoV-2 immunoassay

Eligibility Criteria

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

Study Population

The study population is composed of individuals aged 18 years or older, in an active phase of treatment for any invasive cancer.

You may qualify if:

• Patients ≥18 years old
• Patient diagnosed with invasive cancer (solid tumor only)
• Patient in active phase of cancer treatment (surgery, chemotherapy, radiotherapy, immunotherapy or targeted therapy ongoing or planned within the next month- excepted patient treated by hormonotherapy and targeted therapy alone in adjuvant setting)
• Information and non-opposition of the patient to the study procedure

You may not qualify if:

• Person deprived of their liberty or under protective custody or guardianship
• Patients unwilling or unable to comply with the medical follow-up required by the study because of geographic, familial, social, or psychological reasons
• Patients treated for a hematological malignancy
• Life expectancy \<6 months

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (7)

Centre Hospitalier de Boulogne sur Mer

Boulogne-sur-Mer, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Hopitaux Civils de Colmar

Colmar, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Location

Institut Curie

Paris, France

Location

Centre Eugène Marquis

Rennes, France

Location

Institut Curie

Saint-Cloud, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Neoplasms; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• François-Clément BIDARD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 29, 2020
• Study Start: May 23, 2020
• Primary Completion: May 31, 2021
• Study Completion: April 30, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)