NCT04804436

Brief Summary

In the present study investigators aimed to investigate whether homeodomain interacting protein kinase 2 (HIPK2) polymorphism is associated with renal stone formation in Turkish population or not. One hundred and twenty nine participants with calcium nephrolithiasis and 67 sex and age-matched healthy controls were enrolled in this study. For analysis of HIPK2 polymorphism, the real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination. Chi square test was utilized to compare the differences of the genotype and allele frequencies between patients and controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 14, 2021

Last Update Submit

March 17, 2021

Conditions

Keywords

KSD HIPK2 gene Polymorphism

Outcome Measures

Primary Outcomes (1)

  • Single nucleotide polymorphism

    Single nucleotide polymorphism incidence on rs2058265, rs6464214, and rs7456421

    One year

Study Arms (2)

Patients with nephrolithiasis

EXPERIMENTAL

The real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94℃ for 3 min, 40 cycles of 94℃ for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.

Genetic: Genetic analysis

Healthy control group

EXPERIMENTAL

he real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94℃ for 3 min, 40 cycles of 94℃ for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.

Genetic: Genetic analysis

Interventions

he real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94℃ for 3 min, 40 cycles of 94℃ for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.

Healthy control groupPatients with nephrolithiasis

Eligibility Criteria

Age38 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with nephrolithiasis

You may not qualify if:

  • Patients had a history of chronic urinary tract infection
  • renal failure
  • gastrointestinal diseases
  • increased levels of vitamin D
  • sarcoidosis
  • primary hyperoxaluria
  • polycystic kidney disease, gout, renal tubular acidosis, primary and secondary hyperparathyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omer Gokhan Doluoglu

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Cavit Ceylan, Professor

    University of Medical Sciences, Ministry of Health, Ankara City Hospital, Department of Urology, Ankara, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 18, 2021

Study Start

August 1, 2018

Primary Completion

October 6, 2019

Study Completion

October 6, 2019

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations