Clinical trial NCT04582890: US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis
Official title: US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glomerulonephritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patientswith acute glomerulonephritis either poststreptococcal , lupus, ANCA related, or Ig A nephritis . Diagnosis of such diseases will be done through usual clinical, laboratory , radiological and histopathological data

Brief summary: US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis

Detailed description: Glomerulonephritis (GN) comprises a group of renal diseases characterized by glomerular and tubulointerstitial fibrosis secondary to glomerular inflammation and proliferation of the basement membrane, mesangial cells, or capillary endothelium triggered by immunologic mechanisms.(1) The glomerular filtration rate decreases with progression of chronic kidney disease (CKD), ultimately resulting in end-stage renal failure. Glomerulonephritis is the third most common cause of end-stage renal failure. Initial clinical signs of glomerulonephritis are nonspecific and subtle. Occasionally, affected patients present with hypertension, proteinuria, hematuria, raised serum creatinine level, weight gain, edema, or nephrotic syndrome.(2) The underlying pathologic changes are partly irreversible, and a prompt diagnosis with early initiation of treatment is of vital importance. The diagnosis is based on clinical, laboratory, and conventional US findings, whereas renal biopsy is considered the reference standard for a definitive diagnosis and fibrosis grading.(3,4) Unfortunately, this invasive procedure is associated with the risk of serious bleeding complications and therefore is not the method of choice for longitudinal monitoring.

Elastography, a Novel imaging modality that estimates tissue stiffness, especially for superficial organs such as the breast and Thyroid. In recent years, ultrasound elastography (UE) has been demonstrated in the liver and has been applied widely in the diagnosis and evaluation of liver diseases, such as chronic hepatitis, alcoholic liver diseases, and non alcoholic fatty liver diseases.(5,6) To date, renal allograft stiffness (elasticity) has been evaluated by magnetic resonance elastography (MRE) and ultrasound elastography (UE). However, UE application for native renal diseases has not been well up till now.(7) Conventional renal ultrasonography may be appropriate to evaluate kidney size, as well as to assess the echogenicity of the renal cortex, exclude obstruction, and determine the extent of fibrosis. However, It has no significant role in diagnosis of GN. US time-harmonic elastography depicts abnormal renal stiffness in glomerulonephritis, particularly among patients with early disease and preserved renal function.(8,9,10)

Eligibility criteria: Inclusion Criteria:

1. Age 1 month up to 18 years
2. Patientswith acute glomerulonephritis either poststreptococcal , lupus, ANCA related, or Ig A nephritis . Diagnosis of such diseases will be done through usual clinical, laboratory , radiological and histopathological data

Exclusion Criteria:

patients with clinical, laboratory , or radiological evidence of chronic kidney disease

Primary outcomes:
measure: The diagnostic performance of US time-harmonic elastography for the early detection of glomerulonephritis will be assessed with calculation of its sensitivity ,specificity and accuracy
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: