Castleman DiseaseNCT05440305
Unicentric Form of Castleman Disease - Surgery Therapy Benefit
An observational study of Castleman Disease and Unicentric Castleman Disease, run by Charles University, Czech Republic.
Trial summary
Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Castleman Disease, Unicentric Castleman Disease, Surgery
- What is being tested?
- surgery type/exstirpation/debulking
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group of patients with unicentric form of Castleman disease
Who may be able to join
- patient with unicentric form of Castleman disease
- underwent surgery resection
Who cannot join
- multilocalised Castleman disease
About this study
Official title: 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.
- Conditions
- Castleman Disease, Unicentric Castleman Disease, Surgery
- Being tested
- surgery type/exstirpation/debulking
- Keywords
- Unicentric form of Castleman disease, Surgical resection
- Medical subject headings
- Castleman Disease, Angiolymphoid Hyperplasia with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery type/exstirpation/debulkingProcedure or surgery
Evaluation of benefit according to surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year survival
surgery treatment success
Measured: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
recurence rate
surgery treatment success
Measured: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jan 2011
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castleman DiseaseStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiri Molacek, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440305
- Sponsor's protocol ID
- 750923
- Status last verified
- Jun 2022
- First submitted
- 11 May 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Castleman Disease - Diagnosis and Surgery
- ClinicalTrials.gov ID
- NCT05440305
- Acronym / sponsor ID
- 750923
- Conditions
- Castleman Disease, Unicentric Castleman Disease, Surgery
- Keywords
- Unicentric form of Castleman disease, Surgical resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Jun 2022 (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.
Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group of patients with unicentric form of Castleman disease
Key inclusion criteria (2 listed)
- patient with unicentric form of Castleman disease
- underwent surgery resection
Key exclusion criteria (1 listed)
- multilocalised Castleman disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery type/exstirpation/debulkingEvaluation of benefit according to surgery | Procedure or surgery | – |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Castleman Disease and Unicentric Castleman Disease, run by Charles University, Czech Republic.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year survival (time frame: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.