Ankylosing SpondylitisNCT05997108
Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Sohag University at 1 site in Egypt.
Trial summary
this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and platelet volume indices levels as biomarkers in ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- CBC
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Feb 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS -AGE MORE THAN 18 YEARS
Who may be able to join
- PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS
- AGE MORE THAN 18 YEARS
Who cannot join
- PATIENT WITH CARDIAC ,CEREBROVASCULAR AND HEMATOLOGIC DIEASE
- PTIENT WITH HYPERTENSION ,DIABETES ,METABOLIS SYNDROMES AND OTHER AUTOIMMUNE RHEUMATIC DISEASES.
Trial locations and contacts
1 site in 1 country.
MOHAMMED A ESMAIL, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spodylitis
this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and platelet volume indices levels as biomarkers in ankylosing spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- CBC
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCDiagnostic test
Platelet and red blood cell volume indices
| Study group | Role | What they receive |
|---|---|---|
| cases group | Not described Receives: Diagnostic Test: CBC | |
| control group | Not described Receives: Diagnostic Test: CBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet
platelet cell volume indices
Measured: 6 months
Red blood cell
red blood cell volume indices
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margo Gerges Mofeed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997108
- Sponsor's protocol ID
- Soh-Med-23-07-01MS
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Azab B, Torbey E, Singh J, Akerman M, Khoueiry G, McGinn JT, Widmann WD, Lafferty J. Mean platelet volume/platelet count ratio as a predictor of long-term mortality after non-ST-elevation myocardial infarction. Platelets. 2011;22(8):557-66. doi: 10.3109/09537104.2011.584086. Epub 2011 Jun 30.
PubMed 21714700Coutant F, Miossec P. Evolving concepts of the pathogenesis of rheumatoid arthritis with focus on the early and late stages. Curr Opin Rheumatol. 2020 Jan;32(1):57-63. doi: 10.1097/BOR.0000000000000664.
PubMed 31644463Bekdas M, Goksugur SB, Sarac EG, Erkocoglu M, Demircioglu F. Neutrophil/lymphocyte and C-reactive protein/mean platelet volume ratios in differentiating between viral and bacterial pneumonias and diagnosing early complications in children. Saudi Med J. 2014 May;35(5):442-7.
PubMed 24825803Kumano Y, Hasegawa Y, Kawahara T, Yasui M, Miyoshi Y, Matsubara N, Uemura H. Pretreatment Neutrophil to Lymphocyte Ratio (NLR) Predicts Prognosis for Castration Resistant Prostate Cancer Patients Underwent Enzalutamide. Biomed Res Int. 2019 Jan 20;2019:9450838. doi: 10.1155/2019/9450838. eCollection 2019.
PubMed 30800682
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spodylitis
- ClinicalTrials.gov ID
- NCT05997108
- Acronym / sponsor ID
- Soh-Med-23-07-01MS
- Conditions
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 Aug 2023 (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.
this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and platelet volume indices levels as biomarkers in ankylosing spondylitis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Diagnostic Test: CBC |
| control group | – | Diagnostic Test: CBC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS -AGE MORE THAN 18 YEARS
Key inclusion criteria (2 listed)
- PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS
- AGE MORE THAN 18 YEARS
Key exclusion criteria (2 listed)
- PATIENT WITH CARDIAC ,CEREBROVASCULAR AND HEMATOLOGIC DIEASE
- PTIENT WITH HYPERTENSION ,DIABETES ,METABOLIS SYNDROMES AND OTHER AUTOIMMUNE RHEUMATIC DISEASES.
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 |
|---|---|---|
| CBCPlatelet and red blood cell volume indices | Diagnostic test | cases group, control group |
Primary outcome
platelet
Time frame: 6 months
platelet cell volume indices
Red blood cell
Time frame: 6 months
red blood cell volume indices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 21714700Azab B, Torbey E, Singh J, Akerman M, Khoueiry G, McGinn JT, Widmann WD, Lafferty J. Mean platelet volume/platelet count ratio as a predictor of long-term mortality after non-ST-elevation myocardial infarction. Platelets. 2011;22(8):557-66. doi: 10.3109/09537104.2011.584086. Epub 2011 Jun 30.
- Background: PubMed 31644463Coutant F, Miossec P. Evolving concepts of the pathogenesis of rheumatoid arthritis with focus on the early and late stages. Curr Opin Rheumatol. 2020 Jan;32(1):57-63. doi: 10.1097/BOR.0000000000000664.
- Background: PubMed 24825803Bekdas M, Goksugur SB, Sarac EG, Erkocoglu M, Demircioglu F. Neutrophil/lymphocyte and C-reactive protein/mean platelet volume ratios in differentiating between viral and bacterial pneumonias and diagnosing early complications in children. Saudi Med J. 2014 May;35(5):442-7.
- Background: PubMed 30800682Kumano Y, Hasegawa Y, Kawahara T, Yasui M, Miyoshi Y, Matsubara N, Uemura H. Pretreatment Neutrophil to Lymphocyte Ratio (NLR) Predicts Prognosis for Castration Resistant Prostate Cancer Patients Underwent Enzalutamide. Biomed Res Int. 2019 Jan 20;2019:9450838. doi: 10.1155/2019/9450838. eCollection 2019.
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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.
MOHAMMED A ESMAIL, assistant professor contact
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 Ankylosing Spondylitis, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARGO G MOFEED, resident (01276496930, MARGO-GERGES-POST@MED.SOHAG.EDU.EG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05997108, which also lists 4 linked publications.
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 18 Aug 2023.