Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210522771809 Date of Approval: 27/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Association of Vascular Endothelial Growth Factor (VEGF) serum levels And Ankylosing Spondylitis in Egyptian patients
Official scientific title Association of Vascular Endothelial Growth Factor (VEGF) serum levels And Ankylosing Spondylitis in Egyptian patients
Brief summary describing the background and objectives of the trial Angiogenesis, a hallmark of inflammatory activation, is an integral part of pathogenic processes including endothelial cell proliferation and migration and subsequent neoangiogenesis and remodeling in autoimmune diseases. Ankylosing spondylitis (AS) is characterized by increased vascularity and vascular lesions. Vascular endothelial growth factor (VEGF) is a potent angiogenic factor and has some pro-inflammatory activity. It has also been suggested that VEGF may be relevant for new bone formation in AS. The aim of this study is to evaluate the serum VEGF levels in Egyptian patients with AS, and its relation to disease-related parameters including radiographic outcomes
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ankylosing spondylitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/11/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL not applicable
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group evaluate the serum VEGF levels in Egyptian patients with AS not applicable All patients will undergo the following only once throughout the time of study : 1- Full medical history, and thorough clinical examination, with the following data to be recorded: age, sex, hip involvement, peripheral arthritis, eye involvement. 2- Disease activity in AS was scored with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). And Bath Ankylosing Spondylitis functional index (BASFI) will be done (Calin et al., 1994). 3-Laboratory investigations: CBC ESR CRP HBA1C HLA-B27 4-SerumVEGF levels were measured by using enzyme-linked immunosorbent assay (ELISA) according to the manufacturer’s directions. 5- Radiological investigations: plain x-ray of both sacroiliac joints anteroposterior view, sacroiliac grading will be performed using New York criteria (Linden et al., 1984). The aim of this study is to evaluate the serum VEGF levels in Egyptian patients with AS, and its relation to disease-related parameters including radiographic outcomes. 35
Control Group evaluate the serum VEGF levels in Egyptian not applicable once evaluate the serum VEGF levels in the Egyptian normal population 35 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult AS(ankylosing spondylitis ) patients 20-60 years old met the modified New York criteria for AS. Patients with any associated rheumatic diseases. - patients with cancers. - Diabetic patients Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/09/2022 FWA 000017585.
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya, Cairo Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the serum VEGF levels in Egyptian patients with AS after 2 months
Secondary Outcome serum VEGF levels in Egyptian patients with AS, and its relation to disease-related parameters including radiographic outcomes. 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator 56 Ramsis St., Abbasseya Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hossam salaheldin Abdelmohsen Labib 56 Ramsis St., Abbasseya Cairo 11566 Egypt University
Secondary Sponsor Salwa Galal Moussa 56 Ramsis St., Abbasseya Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salwa Galal dr_salwa08@yahoo.com 01000652427 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Hossam Labib dr.sam789@yahoo.com 01002058687 56 Ramsis St., Abbasseya, Cairo
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Rasha Hassan dr.sam789@yahoo.com 01002058687 56 Ramsis St., Abbasseya, Cairo
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data (including data dictionaries) will be shared, what data, in particular, will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan) Statistical Analysis Plan,Study Protocol Immediately following publication, No end date The datasets used and/or analyzed during the current study are available from the corresponding author by sending an email upon reasonable request from the Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information