Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN

NCT05850845 | Unknown

• 1 other identifier: HSI in CTX treaatment of IMN
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators propose hyperspectral imaging analysis as a method to distinguish the efficacy of hormone-combined cyclophosphamide therapy for PMN, and classify sensitive and insensitive patients treated with hormone-combined cyclophosphamide regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.

Conditions

Hyperspectral Imaging; Idiopathic Membranous Nephropathy; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Microhyperspectral image of a transrenal specimen

  The microscopic hyperspectral images could accurately distinguish the remission group from the remission group with an accuracy of more than 80%

  2023.3-2023.12

Study Arms (2)

CTX group in remission

The patients with idiopathic membranous nephropathy were divided into two groups: the group in remission and the group without remission after the application of cyclophosphamide. The pathological sections of the kidneys of the two groups were observed by microhyperspectral imaging system, and the differences between the two groups of patients under the spectrum were analyzed.

Device: Microscopic hyperspectral imaging system

CTX group without remission

The patients with idiopathic membranous nephropathy were divided into two groups: the group in remission and the group without remission after the application of cyclophosphamide. The pathological sections of the kidneys of the two groups were observed by microhyperspectral imaging system, and the differences between the two groups of patients under the spectrum were analyzed.

Device: Microscopic hyperspectral imaging system

Interventions

Microscopic hyperspectral imaging system DEVICE

CTX for idiopathic membranous nephropathy

CTX group in remission; CTX group without remission

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinical manifestations of massive albuminuria and confirmed by renal biopsy as idiopathic membranous nephropathy.

You may qualify if:

• Over 18 years old;
• Patients with idiopathic membranous nephropathy confirmed by renal biopsy;
• Had not received hormone and/or immunosuppressive therapy before renal biopsy;
• Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

You may not qualify if:

• There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc. ;
• Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
• Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
• Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
• Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor;
• Patients with follow-up time less than 6 months, incomplete data or missed diagnosis;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Renal aspiration biopsy pathology

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Wang Zunsong, doctor

CONTACT

18660190175; wzsong3@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Qianfo Mountain Hospital of Shandong Province

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: May 9, 2023
• Study Start: June 25, 2023
• Primary Completion: July 20, 2023
• Study Completion: December 30, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04