- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05440305
Unicentric Form of Castleman Disease - Surgery Therapy Benefit
June 28, 2022 updated by: Jiri Molacek, Charles University, Czech Republic
Castleman Disease - Diagnosis and Surgery
Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit.
Observation of surgical treatment strategy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Group of patients with unicentric form of Castleman disease
Description
Inclusion Criteria:
- patient with unicentric form of Castleman disease
- underwent surgery resection
Exclusion Criteria:
- multilocalised Castleman disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5 year survival
Time Frame: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
|
surgery treatment success
|
each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
|
|
recurence rate
Time Frame: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
|
surgery treatment success
|
each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Actual)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 750923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.