- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041764
RNA Sequencing of Individual Versus Wastewater - SARS-CoV2 (Cagablea)
September 3, 2021 updated by: Centre Hospitalier Universitaire de Nice
A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing
The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples.
About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020).
The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined.
These values were compared to values measured in wastewater.
Study Overview
Study Type
Observational
Enrollment (Actual)
1409
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- Nice hospital
-
Sophia Antipolis, France, 06
- Ipmc . Cnrs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
nice population
Description
Inclusion Criteria:
- whole population tested in Nice during W43 of 2020
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PCR positive
samples that are positive for the detection of SARS-CoV2.
The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed
|
No INTERVENTION
|
PCR negative
samples that are p negative for the detection of SARS-CoV2.
T
|
No INTERVENTION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RTqPCR result
Time Frame: 1 month
|
positive ou negative result to SAR-Cov2
|
1 month
|
SARS-CoV2 sequence
Time Frame: 1 month
|
analyse of SARS-CoV2 sequence (in the case of positive samples)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
September 3, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21DSP-IPMC01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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