HRR as a Novel Biomarker in Sjögren's Syndrome

NCT05633524 | Completed

• 1 other identifier: KY202226
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Sjögren's syndrome (SS) is an autoimmune disorder characterized by chronic salivary and lacrimal gland dysfunction leading to dry mouth (xerostomia) and dry eye (xerophthalmia) sensation (1). Although dry mouth and dry eye are the main symptoms, the disease may influence many organs and systems. Diagnosis is made with ocular surface staining scores, anti-SS-A/SS-B auto-antibody positivity, and minor salivary gland biopsy (2). The Complete blood count (CBC) is a simple, inexpensive, accessible, and routinely used laboratory parameter that can be linked to oxidative stress, inflammation and microvascular flow resistance. Parameters include NLR and PLR values may be calculated by using CBC parameters (3). Neutrophil/lymphocyte ratio is used as an inflammatory marker in the diagnosis and prognosis of many cardiovascular diseases, malignancies, and infections (4-6). Peripheral inflammatory biomarkers of hematologic indices had been suggested by numerous studies to play a role during SS onset and progression.

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• HRR

  hemoglobin-to-red cell distribution width ratio

  change from baseline at 24 months

Study Arms (2)

89 SS patients

The medical records were analyzed retrospectively about the 89 patients with first onset of SS (SS group)

Other: blood sample analysis

89 healthy control subjects

The medical records were analyzed retrospectively about the 89 age- and gender-matched individuals (Control group) who presented with normal control.

Other: blood sample analysis

Interventions

blood sample analysis OTHER

All subjects went through a routine ocular examination, and the peripheral venous blood samples were collected and analyzed

89 SS patients; 89 healthy control subjects

Eligibility Criteria

• Age: 45 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 89 SS patients and 89 age- and gender-matched healthy subjects were included. Eighty-nine primary SS patients who met the 2012 American College of Rheumatology (ACR-2012) classification criteria and 89 healthy controls were enrolled.

You may qualify if:

• must meet the 2012 American College of Rheumatology classification criteria,
• without systemic diseases, such as hypertension, diabetes, cardiovascular diseases, and chronic obstructive pulmonary disease,
• without malignant tumors,
• without renal failure,
• without liver diseases,
• without anemia,
• without smoking and alcohol consumption,
• without active infection,
• without other autoimmune diseases,
• without medicine usage that could influence the blood coagulation state,
• without a history of concurrent ocular diseases or trauma,
• without any surgery within three months.

You may not qualify if:

• systemic diseases, such as hypertension, diabetes, cardiovascular diseases, and chronic obstructive pulmonary disease,
• malignant tumor,
• renal failure,
• liver diseases,
• anemia,
• smoking and alcohol consumption,
• active infection,
• other autoimmune diseases,
• medicine usage that could influence the blood coagulation state,
• a history of concurrent ocular diseases or trauma,
• any surgery within three months.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (3)

• Psianou K, Panagoulias I, Papanastasiou AD, de Lastic AL, Rodi M, Spantidea PI, Degn SE, Georgiou P, Mouzaki A. Clinical and immunological parameters of Sjogren's syndrome. Autoimmun Rev. 2018 Oct;17(10):1053-1064. doi: 10.1016/j.autrev.2018.05.005. Epub 2018 Aug 10.

  PMID: 30103041 RESULT

• Yildiz F, Gokmen O. Haematologic indices and disease activity index in primary Sjogren's syndrome. Int J Clin Pract. 2021 Mar;75(3):e13992. doi: 10.1111/ijcp.13992. Epub 2021 Jan 19.

  PMID: 33405348 RESULT

• Hu ZD, Sun Y, Guo J, Huang YL, Qin BD, Gao Q, Qin Q, Deng AM, Zhong RQ. Red blood cell distribution width and neutrophil/lymphocyte ratio are positively correlated with disease activity in primary Sjogren's syndrome. Clin Biochem. 2014 Dec;47(18):287-90. doi: 10.1016/j.clinbiochem.2014.08.022. Epub 2014 Sep 7.

  PMID: 25204965 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yan Wang

  Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: October 29, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

CN (1)