Unicentric Form of Castleman Disease - Surgery Therapy Be... | NCT05440305

Studies
Unicentric Form of Castleman Disease - Surgery Therapy Benefit

NCT05440305

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Jun 30, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Castleman Disease
Unicentric Castleman Disease
Surgery

Interventions

surgery type/exstirpation/debulking

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

May 11, 2022

First Submission Date that Met QC Criteria

Jun 28, 2022

First Posted Date

Jun 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2022

Last Update Posted Date

Jun 30, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiri Molacek, Principal investigator, Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery type/exstirpation/debulking	Procedure	Evaluation of benefit according to surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5 year survival	surgery treatment success	each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
recurence rate	surgery treatment success	each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with unicentric form of Castleman disease
underwent surgery resection

Exclusion Criteria:

multilocalised Castleman disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Group of patients with unicentric form of Castleman disease

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005871	Castleman Disease
D000796	Angiolymphoid Hyperplasia with Eosinophilia

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided