Brucella Serology and History of Brucellosis in Patients... | NCT04911283

Studies
Brucella Serology and History of Brucellosis in Patients With Modic Changes Type 1

NCT04911283

Sponsor

Veysel Delen

Status

Completed

Last Update Posted

Jun 3, 2021Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Brucellosis
Spinal Degeneration

Interventions

Brucella serology test
Medical history for brucellosis

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

Jun 1, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2021

Last Update Posted Date

Jun 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veysel Delen, Department of Physical Medicine and Rehabilitation, Sanliurfa Mehmet Akif Inan Education and Research HospitalSponsor-Investigator

Lead Sponsor

Veysel DelenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: This study aims to examine Brucella serology and history of brucellosis in patients with lumbar Modic changes (MCs) type 1, considering results from cross-sectional and case-control comparisons.

Design: In comparative cross-sectional design, MCs type 1 patients (study group) and MCs type 2 patients (comparator group) were examined in terms of Brucella serology by using agglutination with Coombs test. In addition, in comparative case-control design, both of the MCs groups and age/sex-matched healthy controls were investigated for their medical history regarding brucellosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCs type 1 patients (study group; n=37)			Other: Brucella serology test Other: Medical history for brucellosis
MCs type 2 patients (comparator group; n=44)			Other: Brucella serology test Other: Medical history for brucellosis
healthy controls (n=37)			Other: Medical history for brucellosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brucella serology test	Other	MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.	MCs type 1 patients (study group; n=37)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serology for brucellosis		30 minutes
History of brucellosis		7 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with lumbar Modic changes type 1
Patients with lumbar Modic changes type 2
Participant who given informed consent for the study

Exclusion Criteria:

Patients aged<18 years
History of serious lumbar trauma
Lumbar spinal surgery
Scoliosis
Cooperation disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with MCs and age/sex-matched healthy controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veysel Delen	Mehmet Akif İnan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mehmet Akif İnan Hospital		Sanliurfa			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002006	Brucellosis

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055991	Health Records, Personal
D000071198	Pyrin

Ancestor Terms

ID	Term
D008499	Medical Records
D011996	Records
D003625	Data Collection
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided