HIV SeropositivityNCT05983536
The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
An observational study of HIV Seropositivity and Cancer, run by Qianfoshan Hospital.
Trial summary
To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV Seropositivity, Cancer, Blood Disease
- What is being tested?
- HIV Ag +Ab Assay Kit (Sysmex)
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2023to 31 Jul 2025
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients and blood disease patients with age over 18 and have an HIV test in that very day.
Who may be able to join
- Clinical diagnosis of tumor Disease or blood disease
- Blood samples must meet the test requirements
Who cannot join
- N/A
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.
Read the detailed description
First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.
- Conditions
- HIV Seropositivity, Cancer, Blood Disease
- Being tested
- HIV Ag +Ab Assay Kit (Sysmex)
- Medical subject headings
- HIV Seropositivity, Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Ag +Ab Assay Kit (Sysmex)Diagnostic test
Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Cancer patints that confirmed by pathological examination Receives: Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex) | |
| Patients with blood diseases | Bone marrow aspiration and biopsy confirmed the blood disease Receives: Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HIV Ab/Ag results
The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start20 Sep 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia Zhao, Master, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983536
- Sponsor's protocol ID
- 89269678
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The planed will be shared after the clinical trial is completed and the patent protection is obtained
Publications
Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028.
PubMed 35512447Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0.
PubMed 33441741
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
- ClinicalTrials.gov ID
- NCT05983536
- Acronym / sponsor ID
- 89269678
- Conditions
- HIV Seropositivity, Cancer, Blood Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Aug 2023 (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.
To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.
Detailed description
First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)Cancer patints that confirmed by pathological examination |
| Patients with blood diseases | – | Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)Bone marrow aspiration and biopsy confirmed the blood disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients and blood disease patients with age over 18 and have an HIV test in that very day.
Key inclusion criteria (2 listed)
- Clinical diagnosis of tumor Disease or blood disease
- Blood samples must meet the test requirements
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| HIV Ag +Ab Assay Kit (Sysmex)Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula. | Diagnostic test | Cancer patients, Patients with blood diseases |
Primary outcome
The HIV Ab/Ag results
Time frame: through study completion, an average of 1.5 year
The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 35512447Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028.
- Background: PubMed 33441741Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0.
- Individual participant dataSharing planned: Undecided. The planed will be shared after the clinical trial is completed and the patent protection is obtained
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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.
Xia Zhao, Master principal investigator
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and Cancer, run by Qianfoshan Hospital.
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 2 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 9 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanxiang Chen, Ph.D. (0531-89269678, okayhensen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HIV Ab/Ag results (time frame: through study completion, an average of 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05983536, which also lists 2 linked publications.
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 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.