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CompletedNCT04911283Updated Jun 3, 2021

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

An observational study in Brucellosis and Spinal Degeneration, sponsored by Veysel Delen. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Veysel Delen · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
118
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Brucellosis
  • Spinal Degeneration

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03

In context

Brucellosis

15 studies on the registry are indexed under Brucellosis; 6 are open to participants now.

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Lead sponsor

This is the only study on the registry with Veysel Delen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with MCs and age/sex-matched healthy controls

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients aged\<18 years
  • History of serious lumbar trauma
  • Lumbar spinal surgery
  • Scoliosis
  • Cooperation disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
118 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBrucella serology test

    MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.

  • OtherMedical history for brucellosis

    Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.

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What researchers measure

Primary outcomes

  1. Serology for brucellosis

    Time frame: 30 minutes

  2. History of brucellosis

    Time frame: 7 minutes

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Study locations

1 site
  • Mehmet Akif İnan Hospital
    Şanlıurfa, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Jul 2020, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2021
First posted
Jun 3, 2021
StartActual
May 1, 2019
Primary completionActual
Jul 1, 2020
CompletionActual
Jul 1, 2020
Last update
Jun 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04911283
Lead sponsor
Veysel Delen
Responsible party
Veysel Delen (Department of Physical Medicine and Rehabilitation, Sanliurfa Mehmet Akif Inan Education and Research Hospital) — Sponsor-investigator
First posted
Jun 3, 2021
Start date
May 1, 2019
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Jun 3, 2021

Study contacts

Veysel Delen
principal investigator · Mehmet Akif İnan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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