Sickle Cell DiseaseNCT07865039
Inflammatory Markers and Pain in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Assiut University at 1 site in Egypt.
Trial summary
This observational cross-sectional study aims to assess the relationship between inflammatory markers and pain intensity in adult patients with sickle cell disease. The study will evaluate inflammatory markers in patients with different clinical presentations, including steady state and vaso-occlusive crisis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with confirmed sickle cell disease who present to Assiut University Hospitals during the study period. Participants will include patients in different clinical presentations, including steady state and vaso-occlusive crisis. Eligible patients will be enrolled according to the predefined inclusion and exclusion criteria.
Who may be able to join
- Adults aged ≥18 years. Confirmed diagnosis of sickle cell disease. Patients attending or admitted to the Internal Medicine Department during the study period.
- Willingness to participate and provide informed consent.
Who cannot join
- Patients younger than 18 years. Acute infection or sepsis Autoimmune or chronic inflammatory diseases. Malignancy End-stage renal disease on dialysis. Chronic liver disease Blood transfusion within the preceding four weeks Recent surgery or trauma (within the preceding four weeks. Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospitals
Asyut, Asyut Governorate, 71511
Mohamed Elsayed, +201090187469, mohamed.18313631@med.aun.edu.eg
Maha Mohammed Abd-Elaziz, M.D, +2010 97278659, maha.hematology@aun.edu.eg
About this study
Official title: Association Between Inflammatory Markers and Pain Intensity in Patients With Sickle Cell Disease
This observational cross-sectional study aims to assess the relationship between inflammatory markers and pain intensity in adult patients with sickle cell disease. The study will evaluate inflammatory markers in patients with different clinical presentations, including steady state and vaso-occlusive crisis.
Read the detailed description
Sickle cell disease is a chronic hematological disorder characterized by recurrent complications, including painful vaso-occlusive crises. Inflammatory and hematological markers may vary according to the clinical state and may be associated with the severity of pain.
This observational cross-sectional study will evaluate adult patients with sickle cell disease presenting in different clinical states, including steady state and vaso-occlusive crisis. Clinical history and examination findings will be recorded, including pain intensity assessed using the Visual Analog Scale (VAS), type of clinical presentation, duration of crisis, and length of hospital stay when applicable.
Laboratory investigations will include complete blood count with differential, from which neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) will be calculated, as well as C-reactive protein (CRP), lactate dehydrogenase (LDH), and D-dimer. Other relevant routine laboratory investigations will also be recorded when available.
The study will assess the association between inflammatory markers and pain intensity and will compare these markers among different clinical presentations, particularly steady state and vaso-occlusive crisis. The study will also explore relationships between these markers and relevant hematological and biochemical parameters.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients with Sickle Cell Disease | Adult patients with sickle cell disease will be evaluated according to their clinical presentation, including steady state and vaso-occlusive crisis. Clinical data, pain intensity, and relevant laboratory parameters including inflammatory and hematological markers will be assessed. No intervention will be assigned as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the association between NLR, PLR, and CRP levels and pain intensity, as assessed by the Visual Analogue Scale (VAS), among adult patients with sickle cell disease.
Pain intensity will be assessed using the Visual Analog Scale (VAS), and its association with neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and C-reactive protein (CRP) levels will be evaluated in adult patients with sickle cell disease.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sayed Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865039
- Sponsor's protocol ID
- SCD-Inflammatory-Markers-Pain
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mirbeyk M, Misra S, Koneru G, Funaro MC, Rangaraju S, Bakshi N. Blood-based protein biomarkers of sickle cell disease pain: a systematic review and meta-analysis. Pain. 2026 Jan 1;167(1):56-74. doi: 10.1097/j.pain.0000000000003773. Epub 2025 Oct 1.
PubMed 40981515Lard LR, Mul FP, de Haas M, Roos D, Duits AJ. Neutrophil activation in sickle cell disease. J Leukoc Biol. 1999 Sep;66(3):411-5. doi: 10.1002/jlb.66.3.411.
PubMed 10496310Krishnan S, Setty Y, Betal SG, Vijender V, Rao K, Dampier C, Stuart M. Increased levels of the inflammatory biomarker C-reactive protein at baseline are associated with childhood sickle cell vasocclusive crises. Br J Haematol. 2010 Mar;148(5):797-804. doi: 10.1111/j.1365-2141.2009.08013.x. Epub 2009 Dec 8.
PubMed 19995398Nader E, Romana M, Connes P. The Red Blood Cell-Inflammation Vicious Circle in Sickle Cell Disease. Front Immunol. 2020 Mar 13;11:454. doi: 10.3389/fimmu.2020.00454. eCollection 2020.
PubMed 32231672Sundd P, Gladwin MT, Novelli EM. Pathophysiology of Sickle Cell Disease. Annu Rev Pathol. 2019 Jan 24;14:263-292. doi: 10.1146/annurev-pathmechdis-012418-012838. Epub 2018 Oct 17.
PubMed 30332562Conran N, Belcher JD. Inflammation in sickle cell disease. Clin Hemorheol Microcirc. 2018;68(2-3):263-299. doi: 10.3233/CH-189012.
PubMed 29614637Kato GJ, Piel FB, Reid CD, Gaston MH, Ohene-Frempong K, Krishnamurti L, Smith WR, Panepinto JA, Weatherall DJ, Costa FF, Vichinsky EP. Sickle cell disease. Nat Rev Dis Primers. 2018 Mar 15;4:18010. doi: 10.1038/nrdp.2018.10.
PubMed 29542687
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Inflammatory Markers and Pain Intensity in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07865039
- Acronym / sponsor ID
- SCD-Inflammatory-Markers-Pain
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 8 Oct 2026 (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 observational cross-sectional study aims to assess the relationship between inflammatory markers and pain intensity in adult patients with sickle cell disease. The study will evaluate inflammatory markers in patients with different clinical presentations, including steady state and vaso-occlusive crisis.
Detailed description
Sickle cell disease is a chronic hematological disorder characterized by recurrent complications, including painful vaso-occlusive crises. Inflammatory and hematological markers may vary according to the clinical state and may be associated with the severity of pain.
This observational cross-sectional study will evaluate adult patients with sickle cell disease presenting in different clinical states, including steady state and vaso-occlusive crisis. Clinical history and examination findings will be recorded, including pain intensity assessed using the Visual Analog Scale (VAS), type of clinical presentation, duration of crisis, and length of hospital stay when applicable.
Laboratory investigations will include complete blood count with differential, from which neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) will be calculated, as well as C-reactive protein (CRP), lactate dehydrogenase (LDH), and D-dimer. Other relevant routine laboratory investigations will also be recorded when available.
The study will assess the association between inflammatory markers and pain intensity and will compare these markers among different clinical presentations, particularly steady state and vaso-occlusive crisis. The study will also explore relationships between these markers and relevant hematological and biochemical parameters.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients with Sickle Cell Disease | – | –Adult patients with sickle cell disease will be evaluated according to their clinical presentation, including steady state and vaso-occlusive crisis. Clinical data, pain intensity, and relevant laboratory parameters including inflammatory and hematological markers will be assessed. No intervention will be assigned as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with confirmed sickle cell disease who present to Assiut University Hospitals during the study period. Participants will include patients in different clinical presentations, including steady state and vaso-occlusive crisis. Eligible patients will be enrolled according to the predefined inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Adults aged ≥18 years. Confirmed diagnosis of sickle cell disease. Patients attending or admitted to the Internal Medicine Department during the study period.
- Willingness to participate and provide informed consent.
Key exclusion criteria (1 listed)
- Patients younger than 18 years. Acute infection or sepsis Autoimmune or chronic inflammatory diseases. Malignancy End-stage renal disease on dialysis. Chronic liver disease Blood transfusion within the preceding four weeks Recent surgery or trauma (within the preceding four weeks. Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the association between NLR, PLR, and CRP levels and pain intensity, as assessed by the Visual Analogue Scale (VAS), among adult patients with sickle cell disease.
Time frame: At enrollment
Pain intensity will be assessed using the Visual Analog Scale (VAS), and its association with neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and C-reactive protein (CRP) levels will be evaluated in adult patients with sickle cell disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 40981515Mirbeyk M, Misra S, Koneru G, Funaro MC, Rangaraju S, Bakshi N. Blood-based protein biomarkers of sickle cell disease pain: a systematic review and meta-analysis. Pain. 2026 Jan 1;167(1):56-74. doi: 10.1097/j.pain.0000000000003773. Epub 2025 Oct 1.
- Background: PubMed 10496310Lard LR, Mul FP, de Haas M, Roos D, Duits AJ. Neutrophil activation in sickle cell disease. J Leukoc Biol. 1999 Sep;66(3):411-5. doi: 10.1002/jlb.66.3.411.
- Background: PubMed 19995398Krishnan S, Setty Y, Betal SG, Vijender V, Rao K, Dampier C, Stuart M. Increased levels of the inflammatory biomarker C-reactive protein at baseline are associated with childhood sickle cell vasocclusive crises. Br J Haematol. 2010 Mar;148(5):797-804. doi: 10.1111/j.1365-2141.2009.08013.x. Epub 2009 Dec 8.
- Background: PubMed 32231672Nader E, Romana M, Connes P. The Red Blood Cell-Inflammation Vicious Circle in Sickle Cell Disease. Front Immunol. 2020 Mar 13;11:454. doi: 10.3389/fimmu.2020.00454. eCollection 2020.
- Background: PubMed 30332562Sundd P, Gladwin MT, Novelli EM. Pathophysiology of Sickle Cell Disease. Annu Rev Pathol. 2019 Jan 24;14:263-292. doi: 10.1146/annurev-pathmechdis-012418-012838. Epub 2018 Oct 17.
- Background: PubMed 29614637Conran N, Belcher JD. Inflammation in sickle cell disease. Clin Hemorheol Microcirc. 2018;68(2-3):263-299. doi: 10.3233/CH-189012.
- Background: PubMed 29542687Kato GJ, Piel FB, Reid CD, Gaston MH, Ohene-Frempong K, Krishnamurti L, Smith WR, Panepinto JA, Weatherall DJ, Costa FF, Vichinsky EP. Sickle cell disease. Nat Rev Dis Primers. 2018 Mar 15;4:18010. doi: 10.1038/nrdp.2018.10.
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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.
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 Sickle Cell Disease, 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 1 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: opening soon, as of the sponsor's last update on 8 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the association between NLR, PLR, and CRP levels and pain intensity, as assessed by the Visual Analogue Scale (VAS), among adult patients with sickle cell disease. (time frame: At enrollment). 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 NCT07865039, which also lists 7 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 8 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.