ClinicalTrials.gg
Sign In
RecruitingNCT06528197Updated Jul 30, 2024

Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine

An observational study in Primary Sjögren Syndrome, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by China-Japan Friendship Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Sjögren Syndrome
03

In context

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 177 studies on the registry; 110 are open to participants now.

Browse China-Japan Friendship Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with primary Sjögren's syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
30 Months
Patient registry
Yes

Groups and cohorts

  • Exposed group
  • Control group
06

What researchers measure

Primary outcomes

  1. Number of participants with system involvement

    System involvement determined from clinical diagnosis

    Time frame: Baseline , 6 months follow-up

Secondary outcomes

  1. Mortality

    All-cause mortality

    Time frame: Baseline , 6 months follow-up

  2. Number of participants with tumor

    Tumor determined from clinical diagnosis

    Time frame: Baseline , 6 months follow-up

  3. Number of participants with connective tissue disease

    Connective tissue disease determined from clinical diagnosis

    Time frame: Baseline , 6 months follow-up

07

Study locations

1 of 1 sites recruiting
  • Jiaqi Chen
    Beijing, Beijing Municipality 100029, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2024
First posted
Jul 30, 2024
StartActual
Jul 4, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06528197
Lead sponsor
China-Japan Friendship Hospital
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
Qingwen Tao (Chief physician, China-Japan Friendship Hospital) — Principal investigator
First posted
Jul 30, 2024
Start date
Jul 4, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

China-Japan Friendship Hospital →

Start the discussion