Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03235128

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome Steroid-Resistant	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Detailed Description

Childhood nephrotic syndrome is the most frequent glomerular disease that presents during childhood,primarily owing to a disturbed immune function.This disease is characterized by alterations in selectivity at the glomerular capillary wall that lead to an inability to restrict the urinary loss of protein.The syndrome is characterized by the tetrad of nephrotic range proteinuria (>40 mg/m2/hour), hypoalbuminemia (<2.5 g/dl), generalized edema, and hyperlipidemia. It can be congenital or acquired.Currently,serum albumin, lipids, and proteinuria are the common diagnostic markers of childhood NS, but these markers may not accurately predict the outcome of individual patients because of the heterogeneity of the disease. Renal biopsy is more precise for establishing prognosis of renal outcome, but it has potential complications. Repeated monitoring is technically difficult, particularly for children. Therefore, there is still an urgent need to identify new non invasive diagnostic and prognostic biomarkers and new therapeutic targets for this disease.miRNA-30a expression in the serum of patients with nephrotic syndrome and analyzed the correlation between miRNA with largest over expression level and clinical features compared with healthy subjects.miRNA-30a expression level in drug resistant nephrotic syndrome patients was obviously higher than the drug sensitive patients and up-regulated most significantly in mesangial proliferative glomerulonephritis among different pathological types, while it decreased most obviously in glomerular lesions. miRNA-30a could be treated as the molecular marker in predict drug resistance, pathological type of nephrotic syndrome and follow up of resistant cases.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome

Anticipated Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group1 Steroid sensitive nephrotic syndrome(10 cases).	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood. Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
Group2 Steroid resistant nephrotic syndrome(10 cases).	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood. Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
Group3 immunosuppressive resistant nephrotic syndrome(10 cases).	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood. Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
Group4 Refractory nephrotic syndrome(10 cases).	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood. Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
Group5 Normal children as a healthy control group(5 cases).	Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood. Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood

Outcome Measures

Primary Outcome Measures

Percentage of patients with highly expressed serum miRNA30-a in resistant cases of childhood nephrotic syndrome. [3 days]
Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

-Nephrotic children aged from 2 to 18 that admitted to Pediatric Hospital.

Exclusion Criteria:

Congenital or infantile nephrotic syndrome
Other kidney diseases
Abnormal kidney function test

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Teng J, Sun F, Yu PF, Li JX, Yuan D, Chang J, Lin SH. Differential microRNA expression in the serum of patients with nephrotic syndrome and clinical correlation analysis. Int J Clin Exp Pathol. 2015 Jun 1;8(6):7282-6. eCollection 2015.

Responsible Party:

RAMahmoud, Principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03235128

Other Study ID Numbers:

CSOAOSM

First Posted:

Aug 1, 2017

Last Update Posted:

Aug 2, 2017

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nephrotic Syndrome

Nephrosis

Syndrome

Study Results

No Results Posted as of Aug 2, 2017