Enterovirus InfectionsNCT04535648
Detection of Enterovirus Genotypes by CRISPR Technology
An observational study of Enterovirus Infections, run by Children's Hospital of Fudan University.
Trial summary
CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Enterovirus Infections
- What is being tested?
- Non-invasive detection method: CRISPR techonology
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who came to the Children's Hospital of Fudan University and were diagnosed with enterovirus infection.
Who may be able to join
- Patients with clinically suspected or confirmed enterovirus infection
Who cannot join
- Patients with clinical diagnosis of non-enterovirus infection
About this study
Official title: Rapid Identification and Clinical Transformation of Various Enterovirus Genotypes Based on CRISPR Technology
CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection.
Read the detailed description
To construct CRISPR-enterovirus detection system, we screened the targets, primers and CrRNA and evaluated the capability of this detecting system. Samples of feces, blood and cerebrospinal fluid (the remainder of routine testing samples) from 500 children with suspected or confirmed enterovirus infection were examined using the CRISPR technique. To evaluate the CRISPR-enterovirus detection system, real-time PCR and traditional PCR as comparison method was implemented. The method of real-time PCR and traditional PCR were used to detect enterovirus and analyze the genotypes of enterovirus, respectively. According to the results of CRISPR-enterovirus detection system and the comparison method, the positive coincidence rate, negative coincidence rate and consistency of the two methods were calculated. Furthermore, the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus were calculated.
- Conditions
- Enterovirus Infections
- Being tested
- Non-invasive detection method: CRISPR techonology
- Medical subject headings
- Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive detection method: CRISPR techonologyOther
Also called No intervention
This study was a laboratory diagnostic study without any intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful construction of CRISPR-enterovirus detection system
It is a binary variable ("yes/no").If the system meet all the following criteria, it would be setted into "yes" .According to the results of CRISPR-enterovirus detection system and the comparison method：
- the positive coincidence rate and negative coincidence rate are both over 95.0%;
- the value of Kappa using to express the consistency of those two methods is over 0.75;
- the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus are over 90.0% and 95.0%;
- the coefficient of variation between batches is less 15.0%, and each batch detection takes less than 1 hour.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study startApr 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: This clinical trial has been terminated。
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liling Qian, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535648
- Sponsor's protocol ID
- EV-CRISPR.001
- Status last verified
- Jun 2023
- First submitted
- 25 Aug 2020
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Identification and Clinical Transformation of Various Enterovirus Genotypes Based on CRISPR Technology
- ClinicalTrials.gov ID
- NCT04535648
- Acronym / sponsor ID
- EV-CRISPR.001
- Conditions
- Enterovirus Infections
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This clinical trial has been terminated。
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection.
Detailed description
To construct CRISPR-enterovirus detection system, we screened the targets, primers and CrRNA and evaluated the capability of this detecting system. Samples of feces, blood and cerebrospinal fluid (the remainder of routine testing samples) from 500 children with suspected or confirmed enterovirus infection were examined using the CRISPR technique. To evaluate the CRISPR-enterovirus detection system, real-time PCR and traditional PCR as comparison method was implemented. The method of real-time PCR and traditional PCR were used to detect enterovirus and analyze the genotypes of enterovirus, respectively. According to the results of CRISPR-enterovirus detection system and the comparison method, the positive coincidence rate, negative coincidence rate and consistency of the two methods were calculated. Furthermore, the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus were calculated.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who came to the Children's Hospital of Fudan University and were diagnosed with enterovirus infection.
Key inclusion criteria (1 listed)
- Patients with clinically suspected or confirmed enterovirus infection
Key exclusion criteria (1 listed)
- Patients with clinical diagnosis of non-enterovirus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive detection method: CRISPR techonologyAlso: No interventionThis study was a laboratory diagnostic study without any intervention. | Other | – |
Primary outcome
Successful construction of CRISPR-enterovirus detection system
Time frame: At enrollment
It is a binary variable ("yes/no").If the system meet all the following criteria, it would be setted into "yes" .According to the results of CRISPR-enterovirus detection system and the comparison method： 1. the positive coincidence rate and negative coincidence rate are both over 95.0%; 2. the value of Kappa using to express the consistency of those two methods is over 0.75; 3. the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus are over 90.0% and 95.0%; 4. the coefficient of variation between batches is less 15.0%, and each batch detection takes less than 1 hour.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liling Qian study director
Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Enterovirus Infections, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful construction of CRISPR-enterovirus detection system (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.