Infectious Disease ScreeningNCT04471688
Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion
An observational study of Infectious Disease Screening, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Read more about this study
- Who is it for?
- Ages 1 year to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease Screening
- What is being tested?
- infectious disease screening
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to Dec 2021
- 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 year to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study plans to test 10,000 clinical specimens
Who may be able to join
- hosipital patients
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
China1 site
the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410006
About this study
In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.
At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:
- Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.
- Conditions
- Infectious Disease Screening
- Being tested
- infectious disease screening
- Keywords
- nucleic acid, pre-transfusion, pre-operative, pathogen detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infectious disease screeningDiagnostic test
Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening
| Study group | Role | What they receive |
|---|---|---|
| patients | Preoperative patients needing transfusions Receives: Diagnostic Test: infectious disease screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B Infection Analysis result
Nucleic acid examination and serological test
Measured: 20190601-20201231
Hepatitis C Infection Analysis result
Nucleic acid examination and serological test
Measured: 20190601-20201231
HIV Infection Analysis result
Nucleic acid examination and serological test
Measured: 20190601-20201231
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Jun 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Disease ScreeningStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- SANSURE BIOTECH INC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471688
- Sponsor's protocol ID
- ThirdXiangyaMSID
- Status last verified
- Jun 2020
- First submitted
- 10 Jul 2020
- Last updated
- 15 Jul 2020
- 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 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion
- ClinicalTrials.gov ID
- NCT04471688
- Acronym / sponsor ID
- ThirdXiangyaMSID
- Conditions
- Infectious Disease Screening
- Keywords
- nucleic acid, pre-transfusion, pre-operative, pathogen detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- SANSURE BIOTECH INC.
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jul 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.
In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.
At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:
- Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Diagnostic Test: infectious disease screeningPreoperative patients needing transfusions |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study plans to test 10,000 clinical specimens
Key inclusion criteria (1 listed)
- hosipital patients
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| infectious disease screeningExplore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening | Diagnostic test | patients |
Primary outcome
Hepatitis B Infection Analysis result
Time frame: 20190601-20201231
Nucleic acid examination and serological test
Hepatitis C Infection Analysis result
Time frame: 20190601-20201231
Nucleic acid examination and serological test
HIV Infection Analysis result
Time frame: 20190601-20201231
Nucleic acid examination and serological test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease Screening, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Hepatitis B Infection Analysis result (time frame: 20190601-20201231). The study lists 3 primary outcomes in all. 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 15 Jul 2020.