NCT02871050

Brief Summary

The purpose of this study is to create a biobank, which collects, stores, and distributes samples of human tissues, blood, and related health information to qualified scientists, in order to help doctors and researchers better understand why Castleman Disease occurs and develop ways to better treat and prevent it.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

August 15, 2016

Last Update Submit

July 28, 2018

Conditions

Castleman DiseaseCastleman's DiseaseGiant Lymph Node HyperplasiaAngiofollicular Lymph HyperplasiaAngiofollicular Lymph Node HyperplasiaAngiofollicular Lymphoid HyperplasiaGLNHHyperplasiaGiant Lymph Node

Keywords

BiobankbiorepositoryCastlebankCastleman DiseaseCDMCDiMCDCastlemanCastleman's Diseasemulticentric Castleman's diseasemulticentric Castleman diseaseAngiofollicular Lymph Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Samples Collected

    Number of samples collected across different subgroups (e.g. blood products, lymph node)

    3 years

Study Arms (1)

Castleman Disease Patients

Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease.

Other: Sample Collection

Interventions

Sample CollectionOTHER

Excess blood sample tubes and/or buccal swabs or saliva will have DNA and RNA extracted and serum and plasma separated out to be stored for future research purposes based on the results of this preliminary research.

Castleman Disease Patients

Eligibility Criteria

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

Castleman Disease patients worldwide

You may qualify if:

  • Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castleman Disease Collaborative Network

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (2)

  • Liu AY, Nabel CS, Finkelman BS, Ruth JR, Kurzrock R, van Rhee F, Krymskaya VP, Kelleher D, Rubenstein AH, Fajgenbaum DC. Idiopathic multicentric Castleman's disease: a systematic literature review. Lancet Haematol. 2016 Apr;3(4):e163-75. doi: 10.1016/S2352-3026(16)00006-5. Epub 2016 Mar 17.

    PMID: 27063975BACKGROUND

  • Fajgenbaum DC, van Rhee F, Nabel CS. HHV-8-negative, idiopathic multicentric Castleman disease: novel insights into biology, pathogenesis, and therapy. Blood. 2014 May 8;123(19):2924-33. doi: 10.1182/blood-2013-12-545087. Epub 2014 Mar 12.

    PMID: 24622327BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Lymph node and/or bone marrow slides and/or tissue blocks, saliva, whole blood, and serum will be collected both prospectively and retrospectively.

MeSH Terms

Conditions

Castleman DiseaseHyperplasiaMacular dystrophy, corneal type 1Multi-centric Castleman's Disease

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • David C Fajgenbaum, MD, MBA, MSc

    Executive Director of Castleman Disease Collaborative Network

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Qualified Researchers, who apply for access to the database and are subsequently approved, will be given access to a limited dataset with direct identifiers removed in an Excel compatible file format or single SAS data files. The Biobank Advisory Board will review applications from qualified researchers on an ongoing basis.

Locations

US(1)