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.

Sponsor

Charles University, Czech Republic

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

Keywords

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.

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