Behcet SyndromeNCT06729112
Pan-immune-inflammation Value (PIN) in Behçet's Disease and Its Correlation With Disease Activity
An observational study of Behcet Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- pan immune inflammation value
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Mar 2025
- 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: Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease attending Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals.
Who may be able to join
- Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
- Accept to participate in the current study.
Who cannot join
- Individuals with other autoimmune diseases.
- Patients unwilling to participate in the study.
- Patients less than 18 years old.
- Patients with malignancy or infections.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. The aim of present study is to assess pan immune inflammation value (PIN) value in BD in comparison to healthy control ,assess the PIN value in association with demographics and clinical characteristics of Behcet patients and to assess the PIN value in association with disease activity.
Read the detailed description
Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. Inflammation of the vascular wall is the primary pathophysiology contributing to thrombosis in BD. Hematological and biochemical values are altered due to systemic inflammation and aberrant immune response. Neutrophils, lymphocytes, and platelets play a significant role in systemic inflammation and thrombosis. In addition to the number and volume of peripheral cells, changes in multiple cell count ratios, such as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR), have become important predictors of the diagnosis, disease activity, s and severe organ damage in rheumatologic disorders. pan immune inflammation value (PIV) was first described by Fuca et al and used to evaluate the inflammation. Literature showed that PIV performed better than previous immune-inflammatory biomarkers, such as NLR in colorectal cancer patients. PIV is calculated from four blood cell counts, including neutrophils, platelets, monocytes, and lymphocytes. In some rheumatological diseases such as RA, familial Mediterranean fever, and vasculitis, PIV has been studied.
In clinical practice, hematological and inflammatory laboratory tests are easily accessible and cost-effective. It is important to determine which blood parameter will be more effective in detecting disease activity and monitoring the treatment response in BD. In our study, our aim is to investigate the association of PIN with demographics and clinical characteristics of BD patients and its correlation with disease activity.
- Conditions
- Behcet Syndrome
- Being tested
- pan immune inflammation value
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pan immune inflammation valueDiagnostic test
Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count by the platelet count and the monocyte count, and then dividing the result by the lymphocyte count.
| Study group | Role | What they receive |
|---|---|---|
| Behçet's disease | Adult Behçet's disease patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease.
and Accept to participate in the current study. Receives: Diagnostic Test: pan immune inflammation value | |
| control group | healthy matched controls Receives: Diagnostic Test: pan immune inflammation value |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pan immune inflammation value (PIN value) in BD in comparison to healthy control
Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count (109/L) by the platelet count (109/L) and the monocyte count (109/L), and then dividing the result by the lymphocyte count (109/L).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Farrag Ahmed Mohamed, Assiut University
- Investigators
- Sara Farrag, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729112
- Sponsor's protocol ID
- SFA122024
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
PubMed 34531393Bettiol A, Prisco D, Emmi G. Behcet: the syndrome. Rheumatology (Oxford). 2020 May 1;59(Suppl 3):iii101-iii107. doi: 10.1093/rheumatology/kez626.
PubMed 32348523Fuca G, Guarini V, Antoniotti C, Morano F, Moretto R, Corallo S, Marmorino F, Lonardi S, Rimassa L, Sartore-Bianchi A, Borelli B, Tampellini M, Bustreo S, Claravezza M, Boccaccino A, Murialdo R, Zaniboni A, Tomasello G, Loupakis F, Adamo V, Tonini G, Cortesi E, de Braud F, Cremolini C, Pietrantonio F. The Pan-Immune-Inflammation Value is a new prognostic biomarker in metastatic colorectal cancer: results from a pooled-analysis of the Valentino and TRIBE first-line trials. Br J Cancer. 2020 Aug;123(3):403-409. doi: 10.1038/s41416-020-0894-7. Epub 2020 May 19.
PubMed 32424148
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-immune-inflammation Value (PIN) in Behçet's Disease and Its Correlation With Disease Activity
- ClinicalTrials.gov ID
- NCT06729112
- Acronym / sponsor ID
- SFA122024
- Conditions
- Behcet Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 11 Dec 2024 (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.
Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. The aim of present study is to assess pan immune inflammation value (PIN) value in BD in comparison to healthy control ,assess the PIN value in association with demographics and clinical characteristics of Behcet patients and to assess the PIN value in association with disease activity.
Detailed description
Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. Inflammation of the vascular wall is the primary pathophysiology contributing to thrombosis in BD. Hematological and biochemical values are altered due to systemic inflammation and aberrant immune response. Neutrophils, lymphocytes, and platelets play a significant role in systemic inflammation and thrombosis. In addition to the number and volume of peripheral cells, changes in multiple cell count ratios, such as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR), have become important predictors of the diagnosis, disease activity, s and severe organ damage in rheumatologic disorders. pan immune inflammation value (PIV) was first described by Fuca et al and used to evaluate the inflammation. Literature showed that PIV performed better than previous immune-inflammatory biomarkers, such as NLR in colorectal cancer patients. PIV is calculated from four blood cell counts, including neutrophils, platelets, monocytes, and lymphocytes. In some rheumatological diseases such as RA, familial Mediterranean fever, and vasculitis, PIV has been studied.
In clinical practice, hematological and inflammatory laboratory tests are easily accessible and cost-effective. It is important to determine which blood parameter will be more effective in detecting disease activity and monitoring the treatment response in BD. In our study, our aim is to investigate the association of PIN with demographics and clinical characteristics of BD patients and its correlation with disease activity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behçet's disease | – | Diagnostic Test: pan immune inflammation valueAdult Behçet's disease patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease. and Accept to participate in the current study. |
| control group | – | Diagnostic Test: pan immune inflammation valuehealthy matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease attending Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals.
Key inclusion criteria (2 listed)
- Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
- Accept to participate in the current study.
Key exclusion criteria (5 listed)
- Individuals with other autoimmune diseases.
- Patients unwilling to participate in the study.
- Patients less than 18 years old.
- Patients with malignancy or infections.
- Pregnancy and lactation
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 |
|---|---|---|
| pan immune inflammation valueUsing the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count by the platelet count and the monocyte count, and then dividing the result by the lymphocyte count. | Diagnostic test | Behçet's disease, control group |
Primary outcome
Evaluation of pan immune inflammation value (PIN value) in BD in comparison to healthy control
Time frame: 3 months
Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count (109/L) by the platelet count (109/L) and the monocyte count (109/L), and then dividing the result by the lymphocyte count (109/L).
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 9 Jun 2026.
- Background: PubMed 34531393Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
- Background: PubMed 32348523Bettiol A, Prisco D, Emmi G. Behcet: the syndrome. Rheumatology (Oxford). 2020 May 1;59(Suppl 3):iii101-iii107. doi: 10.1093/rheumatology/kez626.
- Background: PubMed 32424148Fuca G, Guarini V, Antoniotti C, Morano F, Moretto R, Corallo S, Marmorino F, Lonardi S, Rimassa L, Sartore-Bianchi A, Borelli B, Tampellini M, Bustreo S, Claravezza M, Boccaccino A, Murialdo R, Zaniboni A, Tomasello G, Loupakis F, Adamo V, Tonini G, Cortesi E, de Braud F, Cremolini C, Pietrantonio F. The Pan-Immune-Inflammation Value is a new prognostic biomarker in metastatic colorectal cancer: results from a pooled-analysis of the Valentino and TRIBE first-line trials. Br J Cancer. 2020 Aug;123(3):403-409. doi: 10.1038/s41416-020-0894-7. Epub 2020 May 19.
- 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.
Sara Farrag, Lecturer principal investigator
Assiut University
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 Behcet Syndrome, run by Assiut 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 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 9 Jun 2026. 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?
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?
Evaluation of pan immune inflammation value (PIN value) in BD in comparison to healthy control (time frame: 3 months). 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 NCT06729112, which also lists 3 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 9 Jun 2026.