NCT05440305

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

11 years

First QC Date

May 11, 2022

Last Update Submit

June 28, 2022

Conditions

Castleman DiseaseUnicentric Castleman DiseaseSurgery

Keywords

Unicentric form of Castleman diseaseSurgical resection

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

surgery type/exstirpation/debulkingPROCEDURE

Evaluation of benefit according to surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Group of patients with unicentric form of Castleman disease

You may qualify if:

  • patient with unicentric form of Castleman disease
  • underwent surgery resection

You may not qualify if:

  • multilocalised Castleman disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Castleman DiseaseAngiolymphoid Hyperplasia with Eosinophilia

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEosinophiliaLeukocyte DisordersHematologic DiseasesGranulomaSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 11, 2022

First Posted

June 30, 2022

Study Start

January 1, 2011

Primary Completion

December 31, 2021

Study Completion

April 30, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share