Sjögren's SyndromeNCT05633524
HRR as a Novel Biomarker in Sjögren's Syndrome
An observational study of Sjögren's Syndrome, run by Tianjin Eye Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- blood sample analysis
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2020to 21 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
- systemic diseases, such as hypertension, diabetes, cardiovascular diseases, and chronic obstructive pulmonary disease,
- malignant tumor,
- renal failure,
- liver diseases,
- anemia,
- smoking and alcohol consumption,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HRR as a Novel Plasma Inflammatory Biomarker in Sjögren's Syndrome: Findings From a Case-control Study
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.
Read the detailed description
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.
Sjögren's syndrome (SS) is a chronic autoimmune disease that primarily affects the exocrine glands, resulting in their functional impairment. In SS, lymphocytic infiltration of salivary and lacrimal glands, and deposition of several types of autoantibodies, mainly anti-SS-A (anti-Ro) and anti-SS-B (anti-La), lead to chronic inflammation, with xerostomia and keratoconjunctivitis sicca. In its primary form (pSS), SS does not involve additional connective tissue diseases. SS presents in association with other rheumatic autoimmune diseases, mainly rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and systemic sclerosis.
Obviously, a prerequisite step in answering this critical question was to depict the change of inflammatory biomarkers of hematologic indices and disease activity progression in a detailed and comprehensive manner, and actually there were several studies aimed at answering this question. Along the hematologic indices field, most of the studies agreed that RDW was critical parameter in SS activity indication.
As in most autoimmune diseases, environmental, hormonal and genetic factors are implicated in SS pathogenesis. have been shown to be a good serum marker in primary SS (pSS). All these indicated a potential linkage between systemic inflammation and the risk of SS. However, sparse evidence has been available on this association between the hematologic indices and SS. The aim of the present study, therefore, was to evaluate the association between systemic inflammation indices and SS.
- Conditions
- Sjögren's Syndrome
- Being tested
- blood sample analysis
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample analysisOther
All subjects went through a routine ocular examination, and the peripheral venous blood samples were collected and analyzed
| Study group | Role | What they receive |
|---|---|---|
| 89 SS patients | The medical records were analyzed retrospectively about the 89 patients with first onset of SS (SS group) Receives: 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. Receives: Other: blood sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRR
hemoglobin-to-red cell distribution width ratio
Measured: change from baseline at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start29 Oct 2020
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Study chair, Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633524
- Sponsor's protocol ID
- KY202226
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30103041Yildiz 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.
PubMed 33405348Hu 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.
PubMed 25204965
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRR as a Novel Plasma Inflammatory Biomarker in Sjögren's Syndrome: Findings From a Case-control Study
- ClinicalTrials.gov ID
- NCT05633524
- Acronym / sponsor ID
- KY202226
- Conditions
- Sjögren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Sjögren's syndrome (SS) is a chronic autoimmune disease that primarily affects the exocrine glands, resulting in their functional impairment. In SS, lymphocytic infiltration of salivary and lacrimal glands, and deposition of several types of autoantibodies, mainly anti-SS-A (anti-Ro) and anti-SS-B (anti-La), lead to chronic inflammation, with xerostomia and keratoconjunctivitis sicca. In its primary form (pSS), SS does not involve additional connective tissue diseases. SS presents in association with other rheumatic autoimmune diseases, mainly rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and systemic sclerosis.
Obviously, a prerequisite step in answering this critical question was to depict the change of inflammatory biomarkers of hematologic indices and disease activity progression in a detailed and comprehensive manner, and actually there were several studies aimed at answering this question. Along the hematologic indices field, most of the studies agreed that RDW was critical parameter in SS activity indication.
As in most autoimmune diseases, environmental, hormonal and genetic factors are implicated in SS pathogenesis. have been shown to be a good serum marker in primary SS (pSS). All these indicated a potential linkage between systemic inflammation and the risk of SS. However, sparse evidence has been available on this association between the hematologic indices and SS. The aim of the present study, therefore, was to evaluate the association between systemic inflammation indices and SS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 89 SS patients | – | Other: blood sample analysisThe medical records were analyzed retrospectively about the 89 patients with first onset of SS (SS group) |
| 89 healthy control subjects | – | Other: blood sample analysisThe medical records were analyzed retrospectively about the 89 age- and gender-matched individuals (Control group) who presented with normal control. |
Who may qualify
- Ages
- 45 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (11 listed)
- systemic diseases, such as hypertension, diabetes, cardiovascular diseases, and chronic obstructive pulmonary disease,
- malignant tumor,
- renal failure,
- liver diseases,
- anemia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample analysisAll subjects went through a routine ocular examination, and the peripheral venous blood samples were collected and analyzed | Other | 89 SS patients, 89 healthy control subjects |
Primary outcome
HRR
Time frame: change from baseline at 24 months
hemoglobin-to-red cell distribution width ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Results publication: PubMed 30103041Psianou 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.
- Results publication: PubMed 33405348Yildiz 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.
- Results publication: PubMed 25204965Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang study chair
Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Syndrome, run by Tianjin Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRR (time frame: change from baseline at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633524, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.