BrucellosisNCT04911283
Brucella Serology and History of Brucellosis in Patients With Modic Changes Type 1
An observational study of Brucellosis and Spinal Degeneration, run by Veysel Delen at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brucellosis, Spinal Degeneration
- What is being tested?
- Brucella serology test and Medical history for brucellosis
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with MCs and age/sex-matched healthy controls
Who may be able to join
- Patients with lumbar Modic changes type 1
- Patients with lumbar Modic changes type 2
- Participant who given informed consent for the study
Who cannot join
- Patients aged<18 years
- History of serious lumbar trauma
- Lumbar spinal surgery
- Scoliosis
- Cooperation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mehmet Akif İnan Education and Research Hospital
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.
- Conditions
- Brucellosis, Spinal Degeneration
- Being tested
- Brucella serology test, Medical history for brucellosis
- Medical subject headings
- Brucellosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brucella serology testOther
MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
Medical history for brucellosisOther
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.
| Study group | Role | What they receive |
|---|---|---|
| MCs type 1 patients (study group; n=37) | Not described Receives: Other: Brucella serology test; Other: Medical history for brucellosis | |
| MCs type 2 patients (comparator group; n=44) | Not described Receives: Other: Brucella serology test; Other: Medical history for brucellosis | |
| healthy controls (n=37) | Not described Receives: Other: Medical history for brucellosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serology for brucellosis
Measured: 30 minutes
History of brucellosis
Measured: 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 May 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrucellosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veysel Delen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Veysel Delen, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Investigators
- Veysel Delen, Principal investigator, Mehmet Akif İnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911283
- Sponsor's protocol ID
- SUEADH
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mehmet Akif İnan Education and Research Hospital
- ClinicalTrials.gov ID
- NCT04911283
- Acronym / sponsor ID
- SUEADH
- Conditions
- Brucellosis, Spinal Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Veysel DelenUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MCs and age/sex-matched healthy controls
Key inclusion criteria (3 listed)
- Patients with lumbar Modic changes type 1
- Patients with lumbar Modic changes type 2
- Participant who given informed consent for the study
Key exclusion criteria (5 listed)
- Patients aged<18 years
- History of serious lumbar trauma
- Lumbar spinal surgery
- Scoliosis
- Cooperation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brucella serology testMCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test. | Other | MCs type 1 patients (study group; n=37), MCs type 2 patients (comparator group; n=44) |
| Medical history for brucellosisBoth of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis. | Other | MCs type 1 patients (study group; n=37), MCs type 2 patients (comparator group; n=44), healthy controls (n=37) |
Primary outcome
Serology for brucellosis
Time frame: 30 minutes
History of brucellosis
Time frame: 7 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veysel Delen principal investigator
Mehmet Akif İnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brucellosis and Spinal Degeneration, run by Veysel Delen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serology for brucellosis (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.