Sickle Cell DiseaseNCT06345638
Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease
An observational study of Sickle Cell Disease and Vaso-occlusive Crisis, run by University of Pennsylvania at 3 sites in United States.
Trial summary
This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD). The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2024to 17 Jun 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individual with sickle cell disease receiving care for vaso-occlusive pain episodes.
Who may be able to join
- Adult males and females aged 18-45
- Diagnosis of sickle cell disease
- current hospitalization for vaso-occlusive pain episode or current outpatient infusion at the recruiting sites
- Able to read and understand English
- Willing to comply with study procedures
Who cannot join
- Currently pregnant, pregnant within the last month, or seeking to become pregnant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19143
About this study
This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).
- The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.
- The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.
- The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
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 |
|---|---|---|
| Females with SCD | Not described | |
| Males with SCD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein level
Serum level of hs-CRP
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Mar 2024
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345638
- Sponsor's protocol ID
- 854343
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06345638
- Acronym / sponsor ID
- 854343
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 3 Apr 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.
This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).
- The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.
- The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.
- The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females with SCD | – | – |
| Males with SCD | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individual with sickle cell disease receiving care for vaso-occlusive pain episodes.
Key inclusion criteria (5 listed)
- Adult males and females aged 18-45
- Diagnosis of sickle cell disease
- current hospitalization for vaso-occlusive pain episode or current outpatient infusion at the recruiting sites
- Able to read and understand English
- Willing to comply with study procedures
Key exclusion criteria (1 listed)
- Currently pregnant, pregnant within the last month, or seeking to become pregnant
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
C-reactive protein level
Time frame: 1 month
Serum level of hs-CRP
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 5 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Vaso-occlusive Crisis, run by University of Pennsylvania at 3 sites in United States.
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 5 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: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
C-reactive protein level (time frame: 1 month). 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 5 Aug 2025.