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Clinical Trials/NCT07208513
NCT07208513Not yet recruitingNot Applicable

Multi-omics Study of Peritoneal Dialysis Effluent to Explore Biomarkers of Peritoneal Fibrosis

Shanghai Jiao Tong University School of Medicine1 site in 1 country55 target enrollmentStarted: October 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
(1) RNA-seq transcriptomics of exfoliated cells; (2) LC-MS metabolomics of permeable supernatant.

Study Overview

Brief Summary

Biomarkers of peritoneal fibrosis in patients with peritoneal dialysis were investigated by transcriptomics of exfoliated cells and metabolomics of exfoliated cells in peritoneal dialysis

Detailed Description

This study is a cross-sectional study with no clinical intervention and follow-up.

Patients who met the inclusion criteria were enrolled in the study, and demographic indicators and clinical hematological indicators were collected within 2 weeks, clinical assessment of peritoneal function and other indicators were collected within 4 weeks, abdominal diarrhea effusion exfoliated cells and supernatant were collected within 4 weeks, and some patients were collected for fibrosis assessment by wall peritoneal samples. After the clinical sample was tested, correlation analysis was performed to explore the biomarkers of peritoneal fibrosis.

  1. Collection of clinical indicators Relevant information such as demographic indicators, primary renal disease, comorbidities, complications, abdominal dialysis regimen, dialysis age, urine output, ultrafiltration volume, peritonitis history, and concomitant medication were recorded.

After the patients were enrolled in the group, they completed a physical examination (weight, blood pressure, BCM measurement, etc.) within 2 weeks, and collected clinical laboratory indicators including whole blood analysis, hsCRP, NT-proBNP, TNI, blood biochemistry (liver and kidney function, electrolytes, blood glucose, HbA1C, blood lipids, calcium, phosphorus, iPTH, iron, total iron binding capacity, ferritin), mGFR, exudate electrolyte, exudate albumin concentration, etc., exudate CA125, and peritoneal CT peritoneal thickness within 3 months. 2. Clinical assessment of peritoneal function Standard peritoneal balance test was performed to evaluate the peritoneal ultrafiltration function (net ultrafiltration volume after 4 hours of 2.5% glucose dialysis solution) and solute transport rate (D/PCR). 3. Peritoneal dialysis effusion collection and exfoliated cell collection 2L of abdominal translate was collected overnight, cell sediment was collected by centrifugation (1500 rpm, 10 min), RNA was extracted by RNA extraction kit for transcriptome sequencing, and the supernatant of the permeate was cryopreserved to -70 oC for metabolomics determination.

3.1 Exfoliated cell RNA-sequencing

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients on peritoneal dialysis: a. Age 18-75 years; b. Regular abdominal dialysis due to uremia> 3 months; c. Signed informed consent
  • Hemodialysis patients: a. Age 18-75 years; b. Due to regular hemodialysis due to uremia> 3 months old, allogeneic kidney transplantation is planned; c. Signed informed consent
  • Patients with normal renal function: a. Age 18-75 years; b. Proposed elective inguinal hernia repair surgery; c. Signed informed consent.

Exclusion Criteria

  • Patients on peritoneal dialysis: a. History of peritonitis in the past 3 months; b. History of abdominal tumors with peritoneal metastases
  • Hemodialysis patients: a. Previous abdominal dialysis history; b. History of abdominal tumors with peritoneal metastases Patients with normal renal function: a. History of chronic kidney disease; b. History of abdominal tumors with peritoneal metastases

Outcomes

Primary Outcomes

(1) RNA-seq transcriptomics of exfoliated cells; (2) LC-MS metabolomics of permeable supernatant.

Time Frame: October 2024 - September 2026

Extract RNA from exfoliated cells in exupine, perform mRNA-seq analysis, collect exudate supernatant at the same time, perform metabolome analysis based on mass spectrometry detection, machine learning analysis of multi-omics data, and explore sensitive biomarkers for predicting peritoneal fibrosis based on the evaluation data of peritoneal samples of some patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Na Jiang

doctor

Shanghai Jiao Tong University School of Medicine

Study Sites (1)

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