NCT06554392

Brief Summary

  • Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
  • The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Sep 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Sep 2024Jul 2027

First Submitted

Initial submission to the registry

August 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 11, 2024

Last Update Submit

August 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.

    Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients to detect ferroptosis process in those patients.

    baseline

Secondary Outcomes (1)

  • The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.

    baseline

Study Arms (3)

Ankylosing Spondylitis patients

Identification of Glutathione Peroxidase 4 in blood.

Diagnostic Test: Blood sample

Axial Psoriatic Arthritis Patients

Identification of Glutathione Peroxidase 4 in blood.

Diagnostic Test: Blood sample

healthy controls

Identification of Glutathione Peroxidase 4 in blood.

Diagnostic Test: Blood sample

Interventions

Blood sampleDIAGNOSTIC_TEST

Blood sample from each subject to detect Glutathione Peroxidase 4.

Ankylosing Spondylitis patientsAxial Psoriatic Arthritis Patientshealthy controls

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected from AS and axial psoriatic arthritis patients presented sequentially at the outpatient clinic and inpatient unit of the Department of Rheumatology, Rehabilitation and Physical Medicine. Faculty of Medicine .Assiut University.in addition to age and sex matched controls.

You may qualify if:

  • Patients diagnosed as ankylosing spondylitis according to ASAS criteria . \[13\]
  • Patients diagnosed as psoriatic arthritis according to CASPAR criteria. \[14\]
  • Age (\>18).

You may not qualify if:

  • Patient with other autoimmune Rheumatic diseases.
  • patients with any of the following conditions: I) severe liver and kidney dysfunction; II) hematopoietic diseases; III) infectious diseases; IV) tumors; or V) other wasting diseases. \[15\]
  • patients received certain drugs (for example, sulfasalazine, artemisinin, statins), and experimental reagents (such as erastin) .\[16\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Dixon SJ, Lemberg KM, Lamprecht MR, Skouta R, Zaitsev EM, Gleason CE, Patel DN, Bauer AJ, Cantley AM, Yang WS, Morrison B 3rd, Stockwell BR. Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012 May 25;149(5):1060-72. doi: 10.1016/j.cell.2012.03.042.

    PMID: 22632970BACKGROUND
  • Chen R, Zhu S, Zeng L, Wang Q, Sheng Y, Zhou B, Tang D, Kang R. AGER-Mediated Lipid Peroxidation Drives Caspase-11 Inflammasome Activation in Sepsis. Front Immunol. 2019 Aug 8;10:1904. doi: 10.3389/fimmu.2019.01904. eCollection 2019.

    PMID: 31440260BACKGROUND
  • Yuan S, Wei C, Liu G, Zhang L, Li J, Li L, Cai S, Fang L. Sorafenib attenuates liver fibrosis by triggering hepatic stellate cell ferroptosis via HIF-1alpha/SLC7A11 pathway. Cell Prolif. 2022 Jan;55(1):e13158. doi: 10.1111/cpr.13158. Epub 2021 Nov 22.

    PMID: 34811833BACKGROUND
  • Gao M, Yi J, Zhu J, Minikes AM, Monian P, Thompson CB, Jiang X. Role of Mitochondria in Ferroptosis. Mol Cell. 2019 Jan 17;73(2):354-363.e3. doi: 10.1016/j.molcel.2018.10.042. Epub 2018 Dec 20.

    PMID: 30581146BACKGROUND
  • Chen X, Kang R, Kroemer G, Tang D. Ferroptosis in infection, inflammation, and immunity. J Exp Med. 2021 Jun 7;218(6):e20210518. doi: 10.1084/jem.20210518. Epub 2021 May 12.

    PMID: 33978684BACKGROUND

MeSH Terms

Conditions

Spondylarthropathies

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marwa Abdelaziz, Prof.

    Rheumatology,Rehabilition,Physical therapy Department ,Assiut university

    STUDY DIRECTOR
  • Marwa Galal, Ass. Prof.

    Rheumatology,Rehabilition,Physical therapy Department ,Assiut university

    STUDY DIRECTOR
  • Nesreen Ibrahim, Dr

    Rheumatology,Rehabilition,Physical therapy Department ,Assiut university

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 15, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

August 15, 2024

Record last verified: 2024-08