Adversity and Its Association With the Development and Expression of Rheumatic Diseases
NCT ID: NCT06386380
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
110 participants
OBSERVATIONAL
2024-06-01
2026-02-01
Brief Summary
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With this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.
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Detailed Description
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Patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience.
Additionally, a peripheral blood sample will be taken to evaluate cellular senescence through CD27, CD28, and CD57 expression, the relative expression of the p16INK4a gene in CD3+ lymphocytes, HLA-DR, CD25, and CD69, and telomere length. Finally, the expression of the severity of the disease will be determined.
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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Patients with rheumatoid arthritis
Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Rheumatic diseases Mistreatment Scale (RDMS)
In 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application.
Routine assessment of patient index data 3 (RAPID-3)
RAPID- 3 measures: function, pain, and patient global status estimate. Each of the three individual measures is scored 0 to 10, for a total of 30
Health Assessment Questionnaire (HAQ)
The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.
WHOQOL-BREF
WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items
Depression, Anxiety and Stress Scale (DASS-21)
DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content.
Brief Resilient Coping Scale
The Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner.
Expression of CDKN2A /p16INK4a
CDKN2A/p16INK4a expression will be measured using the Taqman qPCR assay (TaqMan Universal Master Mix II, with UNG, Applied Biosystems, Foster City, USA) according to the manufacturer's specifications.
Immunophenotype of leukocyte subpopulations
CD4+ and CD8+ subpopulations will be analyzed. Blood samples will be analyzed by 8-color flow cytometry (Becton Dickinson Canto II cytometer) using fluorescently labeled antibodies from Biolegend Inc. (San Diego, USA).
Telomere length
The rLTL will be estimated by quantitative monochromatic multiplex PCR (MM-qPCR). Integrated DNA Technologies, Inc. (IDT, Coralville, IA, USA) will synthesize the primers used for telomere measurements.
Cellular senescence
Expression of co-stimulatory molecules and surface receptors CD27- and CD28-
Interventions
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Rheumatic diseases Mistreatment Scale (RDMS)
In 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application.
Routine assessment of patient index data 3 (RAPID-3)
RAPID- 3 measures: function, pain, and patient global status estimate. Each of the three individual measures is scored 0 to 10, for a total of 30
Health Assessment Questionnaire (HAQ)
The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.
WHOQOL-BREF
WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items
Depression, Anxiety and Stress Scale (DASS-21)
DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content.
Brief Resilient Coping Scale
The Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner.
Expression of CDKN2A /p16INK4a
CDKN2A/p16INK4a expression will be measured using the Taqman qPCR assay (TaqMan Universal Master Mix II, with UNG, Applied Biosystems, Foster City, USA) according to the manufacturer's specifications.
Immunophenotype of leukocyte subpopulations
CD4+ and CD8+ subpopulations will be analyzed. Blood samples will be analyzed by 8-color flow cytometry (Becton Dickinson Canto II cytometer) using fluorescently labeled antibodies from Biolegend Inc. (San Diego, USA).
Telomere length
The rLTL will be estimated by quantitative monochromatic multiplex PCR (MM-qPCR). Integrated DNA Technologies, Inc. (IDT, Coralville, IA, USA) will synthesize the primers used for telomere measurements.
Cellular senescence
Expression of co-stimulatory molecules and surface receptors CD27- and CD28-
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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National Institute of Medical Sciences and Nutrition, Salvador Zubiran
OTHER
Responsible Party
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Virginia Pascual Ramos
Dr
Principal Investigators
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Virginia MD Pascual-Ramos, MD
Role: PRINCIPAL_INVESTIGATOR
IInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Central Contacts
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References
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Baumer Y, Powell-Wiley TM. Interdisciplinary approaches are fundamental to decode the biology of adversity. Cell. 2021 May 27;184(11):2797-2801. doi: 10.1016/j.cell.2021.04.010.
Other Identifiers
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IRE-4906
Identifier Type: -
Identifier Source: org_study_id
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