Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 21, 2022
September 1, 2022
1.1 years
March 3, 2020
September 18, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
: To measure circulating Sirt 3 and Sirt 7 levels in patients with systemic sclerosis and their relation with different clinical manifestations
the amount of Sirt 3 and Sirt 7 will be measured by ELISA
2 years
Influence of Sirt 3 and Sirt 7 in fibrosis in Systemic sclerosis
the amount of Sirt 3 and Sirt 7 will be measured by ELISA
2 years
Study Arms (2)
study group
OTHERBlood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at \< - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
control group
OTHERBlood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at \< - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
Interventions
Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum . Separated serum will be stored at \< - 20c ( avoid repeated freeze - thaw cycles ) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
Eligibility Criteria
You may qualify if:
- Patients with systemic sclerosis diagnosed by 2013 ACR\\EULAR classification criteria of systemic sclerosis
- Patients' age \>18
- rheumatoid arthritis patients as a control .
You may not qualify if:
- Overlap or mixed connective tissue diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 11, 2020
Study Start
September 1, 2022
Primary Completion
October 1, 2023
Study Completion
March 1, 2024
Last Updated
September 21, 2022
Record last verified: 2022-09