NCT01973088

Brief Summary

This study intends to use in patients with renal tissue and blood samples, screening and identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further study of uric acid stone formation mechanism and the occurrence of clinical preventive uric acid stones provide new clues and new intervention targets.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

December 10, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

October 20, 2013

Last Update Submit

December 8, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • micro-RNA

    microRNA microarray:the micro-RNA of kidney tissue

    6 months

Secondary Outcomes (5)

  • Urine

    24 hours

  • 24h urine quantitative analysis

    96 hours

  • Blood biochemistry

    24 hours

  • Stone analysis

    3 weeks

  • hURAT1 transporter protein

    6 months

Study Arms (3)

non-urate calculus

non-calculus

urate calculus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Experiment are divided into uric acid stones group (A), non-uric acid stones group (B), control group (C), A, C recruited 30 patients each group, B group recruited 20 patients.

You may qualify if:

  • A、B group were enrolled standards: ① aged 18-65 years old; ② comply with percutaneous nephrolithotomy lithotripsy indications for surgery; ③ ECT tips ipsilateral normal or mildly impaired renal function.
  • Group C patients were enrolled standards: ① aged 18-65 years old; ② normal renal function, not associated with urinary calculi in patients; ③ cancer patients met radical nephrectomy indications for surgery; ④ emergency trauma patients suffering from kidney resection surgical indications.

You may not qualify if:

  • aged \<18 years or\> 65 years; ② neurological disease or cognitive dysfunction; ③ can not be corrected or uncorrected coagulopathy; ④ associated with diabetes, hypertension and other metabolic diseases; ⑤ accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; ⑥ poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; ⑦ ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness \<1.5cm), structural variation; ⑧ with severe systemic or urinary tract infection; ⑨ ECT tips ipsilateral renal function is severely impaired or solitary kidney.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Southwest Hospital, China

Study Record Dates

First Submitted

October 20, 2013

First Posted

October 31, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Last Updated

December 10, 2013

Record last verified: 2013-09