ClinicalTrials.gg
CompletedNCT06167408Updated Dec 12, 2023

Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients

An observational study in Pemphigus Vulgaris, sponsored by First Affiliated Hospital of Chongqing Medical University. Completed at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by First Affiliated Hospital of Chongqing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
96
Ages
Up to 80 Years
Sex
All
01

Study summary

The objective of this retrospective study was to investigate the factors influencing in-hospital relapse during acute episodes of pemphigus, an autoimmune blistering disease characterized by self-antibodies targeting desmogleins. The study included 96 pemphigus patients hospitalized in China between January 2014 and December 2020. The primary questions addressed by the study were:

What are the risk factors associated with in-hospital relapse during acute episodes of pemphigus? Participants in the study underwent a retrospective analysis using univariate and multivariate Cox regression analysis to identify and understand the various risk factors contributing to in-hospital relapse. This research aimed to contribute valuable insights into the factors influencing the course of pemphigus, providing crucial information for better management and treatment strategies.

Read the detailed description

This retrospective study conducted in China between January 2014 and December 2020 aimed to comprehensively examine factors influencing in-hospital relapse during acute episodes of pemphigus, an autoimmune blistering disease characterized by self-antibodies targeting desmogleins-essential cell adhesion molecules. The study enrolled 96 pemphigus patients who were hospitalized during acute episodes.

Research Questions:

Primary Question:

What are the identifiable risk factors associated with in-hospital relapse in pemphigus patients during acute episodes?

Methods:

Study Type: Retrospective Observational Study Participant Population: 96 pemphigus patients hospitalized in China Duration: January 2014 to December 2020

Main Tasks:

Data Collection:

Retrospective analysis of medical records and clinical data of pemphigus patients during acute hospitalizations.

Identification of demographic information, clinical characteristics, and treatment modalities.

Risk Factor Determination:

Univariate and multivariate Cox regression analysis employed to assess potential risk factors.

Variables considered included demographic factors, disease severity, and specific treatment regimens.

Outcome Measurement:

Identification of in-hospital relapse as the primary outcome. Correlation of relapse occurrence with the identified risk factors.

Results:

Key Findings:

Identification of specific risk factors contributing to in-hospital relapse in pemphigus patients.

Quantification of the impact of demographic and clinical variables on relapse probability.

Significance:

Clinical Implications:

Contribution of valuable insights for clinicians in predicting and managing in-hospital relapse in pemphigus patients.

Informing treatment strategies based on identified risk factors.

Research Contribution:

Expansion of understanding regarding the course and management of pemphigus. Providing a foundation for future prospective studies and the development of targeted interventions.

02

Conditions studied

  • Pemphigus Vulgaris

Browse trials for

03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's enrollment of 96 is above the median of 60 across 21 observational studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study included 96 patients diagnosed with pemphigus who received inpatient treatment at the First Affiliated Hospital of Chongqing Medical University between January 1st, 2014, and December 31st, 2020. The inclusion criteria covered both initial and follow-up cases, without age or sex restrictions. Diagnosis was confirmed through pathological biopsy, classifying pemphigus into different types. Patients underwent routine assessments, received various treatments, and were monitored for complications during hospitalization. Ten patients with multiple hospitalizations for cyclophosphamide pulse therapy and three patients not recovering were excluded.

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

  • inpatients.
  • Pathologic diagnosis of pemphigus.

Exclusion criteria

Exclusion Criteria:

  • Patients hospitalized for cyclophosphamide shock therapy only.
  • Patients who did not recover and were discharged due to personal reasons.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
96 participants (actual)
Patient registry
No

Groups and cohorts

  • Pemphigus patients in the First Affiliated Hospital of Chongqing Medical University
06

What researchers measure

Primary outcomes

  1. in-hospitalization relapse

    the occurrence of in-hospital relapse among pemphigus patients during acute episodes

    Time frame: through hospitalization (Up to 1 month)

07

Study locations

1 site
  • First Affiliated hospital of Chongqing Medical University
    Chongqing, Yuzhong District 400000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jun 2022, 5 months.

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

Registered
Nov 30, 2023
First posted
Dec 12, 2023
StartActual
Jan 1, 2022
Primary completionActual
Jun 1, 2022
CompletionActual
Jun 1, 2022
Last update
Dec 12, 2023
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 Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06167408
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible party
Hanyi Wu (doctor, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Dec 12, 2023
Start date
Jan 1, 2022
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Dec 12, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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.

Start the discussion