Lymphocyte DisorderNCT05392244
Characteristics of Peripheral Blood Lymphocyte Subsets in Children With PNS
An observational study of Lymphocyte Disorder and Nephrotic Syndrome, run by Nanfang Hospital, Southern Medical University.
Trial summary
The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS. This study was aimed at investigating the characteristics of peripheral blood lymphocyte subsets and exploring its value of predicting infection in children with primary… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphocyte Disorder, Nephrotic Syndrome
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 31 Aug 2022
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From September, 2019 to April, 2021, a total of 89 children who were admitted in the Nanfang Hospital Affiliated to Southern Medical University and met the Evidence-based Guidelines for the Diagnosis and Treatment of Children's Hormone Sensitivity, Relapsed/Dependent Nephrotic Syndrome (2016), were enrolled in this study.
Who may be able to join
- age <18 years old
- first PNS episode or PNS in remission
- no history of corticosteroid or immunosuppressor use in the four weeks prior to disease occurrence
Who cannot join
- Subjects with infantile (or congenital) nephrotic syndrome (NS), secondary NS, glomerulonephritis, or systemic disease were excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Profiles of Peripheral Blood Lymphocyte Subsets and Risk Factor of Infection in Children With Primary Nephrotic Syndrome
The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS. This study was aimed at investigating the characteristics of peripheral blood lymphocyte subsets and exploring its value of predicting infection in children with primary nephrotic syndrome (PNS).
Read the detailed description
As a common type of nephrosis in children, primary nephrotic syndrome (PNS) is a clinical syndrome characterized by a heavy proteinuria, hypoalbuminemia, edema, and hyperlipidemia, caused by increased plasma protein permeability of the glomerular filtration membrane. To date, the etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS, especially dysfunction of lymphocytes and lymphocyte subsets.
Lymphocyte subsets level can reflect human cellular immune function, which performs different biological functions, and coordinate with each other to maintain the body's immune function homeostasis. At present, many studies have shown that abnormal cellular immune function is closely related to the pathogenesis of PNS in children. Compared with children with PNS with mild proteinuria, CD8+ T cells were significantly increased in children with large proteinuria, and CD4+ T cells were reduced compared with healthy children and children with stable phase. NK cells are also considered to be an indicator that can assess the prognosis of children with PNS. Abnormal number or function of Regulatory T cells (Treg) may be involved in the occurrence of PNS proteinuria, and the urine protein level of the rat model can be relieved by the increase of Treg cells. Although studies have found abnormalities in the lymphocyte subsets of children with PNS, these conclusions are not consistent, indicating that the relationship between cellular immunity and the pathogenesis of children with PNS remains to be studied.
Children with PNS are susceptible to various of infections. After the application of glucocorticoids, children with PNS are more susceptible to infection, even if the infection is not serious, which can lead to recurrence of PNS or affect the curative efficacy of treatment. Studies have found that corticosteroid therapy affects the distribution of lymphocyte subsets in children with PNS, and changes in the level of CD4+ T cells are related to the occurrence and severity of infection in children with NS. The above studies all indicate that lymphocyte subsets analysis has important research significance in the occurrence and prevention of infections in children with PNS.
In this study, we observed the profiles of peripheral blood lymphocyte subsets in healthy children and children with PNS, and explored the risk factor of infection in children with PNS.
- Conditions
- Lymphocyte Disorder, Nephrotic Syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| active group | Active PNS was defined as a serum albumin concentration of <2.5 g/dL and a urinary protein excretion of >40 mg/m2 per hour with high cholesterol levels. | |
| partial remission group | Partial remission PNS was defined as symptoms between active group and complete remission group. | |
| complete remission group | PNS in remission was defined as no proteinuria using the colorimetric qualitative test and a urinary protein/creatinine ratio of <0.2 on a random urine sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral blood lymphocyte subsets
The percentage and absolute counts of lymphocyte subsets were conducted with a BD Canto Ⅱ flow cytometry (FCM)
Measured: 2019.9-2020.12
biochemical indicators
biochemical indicators which were related to PNS, including 24-hour urine protein (UTP), serum albumin (ALB), serum total cholesterol (CHOL) and serum creatinine (Scr) were collected
Measured: 2019.9-2020.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocyte DisorderStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392244
- Sponsor's protocol ID
- NFEC-2022-076
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Profiles of Peripheral Blood Lymphocyte Subsets and Risk Factor of Infection in Children With Primary Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT05392244
- Acronym / sponsor ID
- NFEC-2022-076
- Conditions
- Lymphocyte Disorder, Nephrotic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 26 May 2022 (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.
The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS. This study was aimed at investigating the characteristics of peripheral blood lymphocyte subsets and exploring its value of predicting infection in children with primary nephrotic syndrome (PNS).
Detailed description
As a common type of nephrosis in children, primary nephrotic syndrome (PNS) is a clinical syndrome characterized by a heavy proteinuria, hypoalbuminemia, edema, and hyperlipidemia, caused by increased plasma protein permeability of the glomerular filtration membrane. To date, the etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS, especially dysfunction of lymphocytes and lymphocyte subsets.
Lymphocyte subsets level can reflect human cellular immune function, which performs different biological functions, and coordinate with each other to maintain the body's immune function homeostasis. At present, many studies have shown that abnormal cellular immune function is closely related to the pathogenesis of PNS in children. Compared with children with PNS with mild proteinuria, CD8+ T cells were significantly increased in children with large proteinuria, and CD4+ T cells were reduced compared with healthy children and children with stable phase. NK cells are also considered to be an indicator that can assess the prognosis of children with PNS. Abnormal number or function of Regulatory T cells (Treg) may be involved in the occurrence of PNS proteinuria, and the urine protein level of the rat model can be relieved by the increase of Treg cells. Although studies have found abnormalities in the lymphocyte subsets of children with PNS, these conclusions are not consistent, indicating that the relationship between cellular immunity and the pathogenesis of children with PNS remains to be studied.
Children with PNS are susceptible to various of infections. After the application of glucocorticoids, children with PNS are more susceptible to infection, even if the infection is not serious, which can lead to recurrence of PNS or affect the curative efficacy of treatment. Studies have found that corticosteroid therapy affects the distribution of lymphocyte subsets in children with PNS, and changes in the level of CD4+ T cells are related to the occurrence and severity of infection in children with NS. The above studies all indicate that lymphocyte subsets analysis has important research significance in the occurrence and prevention of infections in children with PNS.
In this study, we observed the profiles of peripheral blood lymphocyte subsets in healthy children and children with PNS, and explored the risk factor of infection in children with PNS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active group | – | –Active PNS was defined as a serum albumin concentration of <2.5 g/dL and a urinary protein excretion of >40 mg/m2 per hour with high cholesterol levels. |
| partial remission group | – | –Partial remission PNS was defined as symptoms between active group and complete remission group. |
| complete remission group | – | –PNS in remission was defined as no proteinuria using the colorimetric qualitative test and a urinary protein/creatinine ratio of <0.2 on a random urine sample. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- From September, 2019 to April, 2021, a total of 89 children who were admitted in the Nanfang Hospital Affiliated to Southern Medical University and met the Evidence-based Guidelines for the Diagnosis and Treatment of Children's Hormone Sensitivity, Relapsed/Dependent Nephrotic Syndrome (2016), were enrolled in this study.
Key inclusion criteria (3 listed)
- age <18 years old
- first PNS episode or PNS in remission
- no history of corticosteroid or immunosuppressor use in the four weeks prior to disease occurrence
Key exclusion criteria (1 listed)
- Subjects with infantile (or congenital) nephrotic syndrome (NS), secondary NS, glomerulonephritis, or systemic disease were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peripheral blood lymphocyte subsets
Time frame: 2019.9-2020.12
The percentage and absolute counts of lymphocyte subsets were conducted with a BD Canto Ⅱ flow cytometry (FCM)
biochemical indicators
Time frame: 2019.9-2020.12
biochemical indicators which were related to PNS, including 24-hour urine protein (UTP), serum albumin (ALB), serum total cholesterol (CHOL) and serum creatinine (Scr) were collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphocyte Disorder and Nephrotic Syndrome, run by Nanfang Hospital, Southern Medical 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 3 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 26 May 2022. 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 Shuai Chu (18665000310, shine9533@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral blood lymphocyte subsets (time frame: 2019.9-2020.12). The study lists 2 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 26 May 2022.