Primary Sjögren SyndromeNCT06528197
Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine
An observational study of Primary Sjögren Syndrome, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 31 Dec 2026
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary Sjögren's syndrome
Who may be able to join
- Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.
Who cannot join
- Comorbid connective tissue disease other than the disease under research.
- Women who are pregnant or breastfeeding.
- Combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors.
- Other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiaqi Chen
Beijing, Beijing Municipality, 100029
Jiaqi Chen, PhD, +86-010-54205067, jiaqichen19@outlook.com
About this study
Official title: Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese Medicine and Western Medicine Based on Multi-omics
This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.
- Conditions
- Primary Sjögren Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with system involvement
System involvement determined from clinical diagnosis
Measured: Baseline , 6 months follow-up
Secondary outcomes (3)
Mortality
All-cause mortality
Measured: Baseline , 6 months follow-up
Number of participants with tumor
Tumor determined from clinical diagnosis
Measured: Baseline , 6 months follow-up
Number of participants with connective tissue disease
Connective tissue disease determined from clinical diagnosis
Measured: Baseline , 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start4 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Qingwen Tao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528197
- Sponsor's protocol ID
- 2024-1-4065
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lei C, Zhang X, Zhang Y, Fang Y, Chen J, Liu Z, Zhou X, Tang B, Liao J, Huang Z, Yang J, Wang Z, Liu T, Tao Q, Luo J. Sex differences in primary Sjogren's disease: prognostic impact on mortality and cancer. Biol Sex Differ. 2026 Jan 14;17(1):25. doi: 10.1186/s13293-026-00827-7.
PubMed 41530868
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese Medicine and Western Medicine Based on Multi-omics
- ClinicalTrials.gov ID
- NCT06528197
- Acronym / sponsor ID
- 2024-1-4065
- Conditions
- Primary Sjögren Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary Sjögren's syndrome
Key inclusion criteria (1 listed)
- Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.
Key exclusion criteria (4 listed)
- Comorbid connective tissue disease other than the disease under research.
- Women who are pregnant or breastfeeding.
- Combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors.
- Other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with system involvement
Time frame: Baseline , 6 months follow-up
System involvement determined from clinical diagnosis
3 secondary outcomes
Mortality
Time frame: Baseline , 6 months follow-up
Number of participants with tumor
Time frame: Baseline , 6 months follow-up
Number of participants with connective tissue disease
Time frame: Baseline , 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 41530868Lei C, Zhang X, Zhang Y, Fang Y, Chen J, Liu Z, Zhou X, Tang B, Liao J, Huang Z, Yang J, Wang Z, Liu T, Tao Q, Luo J. Sex differences in primary Sjogren's disease: prognostic impact on mortality and cancer. Biol Sex Differ. 2026 Jan 14;17(1):25. doi: 10.1186/s13293-026-00827-7.
- Individual participant dataSharing planned: No
Related trials for Primary Sjögren Syndrome
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Active, not recruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
Primary Sjögren Syndrome
Not yet recruitingPhase 2
Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome
Sjogren Syndrome, Xerostomia
Recruiting
Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Primary Sjögren Syndrome, PET
Active, not recruiting
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
Sjogren's Syndrome
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.
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 Primary Sjögren Syndrome, run by China-Japan Friendship 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with system involvement (time frame: Baseline , 6 months follow-up). 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 NCT06528197, which also lists 1 linked publication.
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 30 Jul 2024.