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Enzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndrome

Enzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036550
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport syndrome

Interventions

Gold Standard:Renal biopsy, skin biopsy and genetic test.
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test

Sponsors

Children's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for patients in the experimental group: children with Alport syndrome were definitely diagnosed in our hospital, and the diagnostic criteria were as follows: A. A clear family history; B. Hematuria or proteinuria; C. GBM thickness imbalance or fracture appeared in renal biopsy electron microscope; D. Accompanied by hearing or eye damage. The normal children with no difference in age and gender were selected as the normal control group. 2. Inclusion criteria for children in the hematuria group: Children with clinical diagnosis of hematuria with no difference in age or gender in the same period were selected as the hematuria control group. The diagnostic criteria for hematuria was >= 3 red blood cells per high power microscopic field of vision in centrifugal-precipitated urine.

Exclusion criteria

Exclusion criteria: 1. Urinary tract infection; 2. urinary calculi and tumors; 3. vascular malformation and trauma; 4. systemic hemorrhagic disease; 5. kidney disease with rash, joint pain and other complications.

Design outcomes

Primary

MeasureTime frame
urine IV collagen a chain;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactXinyu Kuang

Children's Hospital of Shanghai

lovely4@126.com+86 13761601772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026