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

NCT07350369 | Completed DMC

• 1 other identifier: KY20252397-F-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

• Using liquid chromatography to measure the levels of 21 neurotransmitters and 5 biogenic amines in the blood, as well as 51 gut microbiota-derived metabolites in the urine, of patients with kidney stones and those without.

  Blood and urine samples were collected from kidney stone patients and non-stone controls. Absolute concentrations of 21 neurotransmitters (e.g., dopamine, L-tyrosine, serotonin, 5-HIAA, tyramine) and 5 biogenic amines (spermidine, spermine, putrescine, ornithine, arginine) in blood, and 51 gut microbiota-derived metabolites (e.g., uric acid, shikimic acid, L-tryptophan, indoxyl-β-D-glucoside, 4-hydroxyphenylacetic acid, etc.) in urine were quantified using liquid chromatography. All concentrations are reported in ng/g. Statistical analyses compared metabolite levels between groups and assessed their associations with kidney stone disease.

  25.08.01-25.11.01

Study Arms (2)

Nephrolithiasis

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.

Other: Detect the levels of metabolites in blood and urine

Normal

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.

Other: Detect the levels of metabolites in blood and urine

Interventions

Detect the levels of metabolites in blood and urine OTHER

Detect the levels of metabolites in blood and urine

Nephrolithiasis; Normal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged between 18 and 70 years, with or without kidney stones.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• zhang ke ying zhang, doctor

  中国人民解放军空军军医大学第一附属医院

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 9, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)