Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Kidney Stone

Treatments: Other: Detect the levels of metabolites in blood and urine

Study type: Observational

Funder types: Other

Identifiers

NCT07350369

KY20252397-F-1

Details and patient eligibility

About

Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action.

Full description

For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested in clinical laboratories will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing, for further targeted metabolomics analysis. By analyzing the results of targeted metabolomic profiling of amine-related substances, differences in amines and metabolites in blood and urine between kidney stone patients and healthy individuals will be assessed.

By measuring and comparing the levels of amine compounds in blood and their corresponding metabolites in urine, statistical analysis will be performed to identify specific amines that are elevated in blood and whose metabolites are simultaneously increased in urine. The underlying mechanisms of these elevations will be further investigated through experimental studies.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Case Group

• Inpatients treated in the Department of Urology at Xijing Hospital with a diagnosis of renal calculi confirmed by imaging examinations, including abdominal plain radiography, ultrasonography, or computed tomography (CT).
• Aged between 18 and 70 years, regardless of sex.
• Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes.
• Complete medical records available, including medical history, clinical symptoms, physical examination findings, previous treatments, and other relevant information.

Control Group

• Inpatients treated in the Department of Urology at Xijing Hospital with no evidence of kidney stones or other urological diseases, as confirmed by urinary system ultrasonography, abdominal plain radiography, or urinary CT.
• Aged between 18 and 70 years, with sex distribution matched to the case group.
• Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes.
• No history of kidney stones or other urological diseases.

Exclusion Criteria

• Presence of severe systemic diseases that may affect kidney stone formation, including malignant tumors, heart failure, liver failure, or renal failure (serum creatinine > 354 μmol/L).
• Presence of other urological diseases, such as pyelonephritis, renal tuberculosis, renal cysts, or renal tumors.
• Presence of endocrine disorders, including hyperparathyroidism or hyperadrenocorticism.
• Pregnant or lactating women.
• Patients with psychiatric disorders, individuals unable to cooperate with the study, or those with a history of substance abuse or alcoholism.
• History of surgical intervention or extracorporeal shock wave lithotripsy (ESWL) for kidney stones within the past 3 months.
• Current use of medications that may influence kidney stone formation (e.g., diuretics, vitamin D, or calcium supplements) and inability to discontinue these medications.
• Insufficient blood or urine sample volume to meet analytical requirements, or samples that were severely contaminated or of poor quality and unsuitable for analysis.

Trial design

20 participants in 2 patient groups

Nephrolithiasis

Description:

For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed.

Treatment:

Other: Detect the levels of metabolites in blood and urine

Normal

Description:

For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed.

Treatment:

Other: Detect the levels of metabolites in blood and urine