Castleman Disease Collaborative Network Biobank | NCT02871050

Studies
Castleman Disease Collaborative Network Biobank

NCT02871050

Sponsor

Castleman Disease Collaborative Network

Status

Withdrawn

Last Update Posted

Jul 31, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Castleman Disease
Castleman's Disease
Giant Lymph Node Hyperplasia
Angiofollicular Lymph Hyperplasia
Angiofollicular Lymph Node Hyperplasia
Angiofollicular Lymphoid Hyperplasia
GLNH
Hyperplasia
Giant Lymph Node

Interventions

Sample Collection

Countries

United States

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

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

An alternative Biobank Project was initiated.

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Aug 15, 2016

First Submission Date that Met QC Criteria

Aug 17, 2016

First Posted Date

Aug 18, 2016Estimated

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

Jul 28, 2018

Last Update Posted Date

Jul 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

The CDCN proposes to establish a biobank and associated clinical data for Castleman disease. Tissue and fluid (blood and saliva) samples will be collected both prospectively and retrospectively. Blood or saliva samples may also be collected from relatives of Castleman patients. Because of the scarcity of these samples, it will be necessary to make efforts to access all available cases. Many cases will occur at hospitals that do not have an existing relationship with the CDCN and may not have experience with tissue procurement; however, this is the only way to obtain the vast majority of samples. Samples may be used immediately, banked for future use, or further processed into DNA, cell lines, tissue microarrays, etc.

The samples will be stored at Precision for Medicine, a biorepository company that specializes in collection, processing, storage and distribution of biospecimens. Only researchers (US or international) who have applied to the CDCN and have been approved by the Biobank Advisory Board will be eligible to access biospecimens and/or data. The Biobank Advisory Board will be comprised of clinicians and scientists with experience in clinical and investigational practices in Castleman Disease.

Conditions Module

Conditions

Castleman Disease
Castleman's Disease
Giant Lymph Node Hyperplasia
Angiofollicular Lymph Hyperplasia
Angiofollicular Lymph Node Hyperplasia
Angiofollicular Lymphoid Hyperplasia
GLNH
Hyperplasia
Giant Lymph Node

Keywords

Biobank
biorepository
Castlebank
Castleman Disease
CD
MCD
iMCD
Castleman
Castleman's Disease
multicentric Castleman's disease
multicentric Castleman disease
Angiofollicular Lymph Hyperplasia

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sample Collection	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Samples Collected	Number of samples collected across different subgroups (e.g. blood products, lymph node)	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

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

Castleman Disease patients worldwide

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David C Fajgenbaum, MD, MBA, MSc	Executive Director of Castleman Disease Collaborative Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Castleman Disease Collaborative Network		Philadelphia	Pennsylvania	19146	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27063975	Background	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.
24622327	Background

ID	Term
D005871	Castleman Disease
D006965	Hyperplasia
C537834	Macular dystrophy, corneal type 1
C537372	Multi-centric Castleman's Disease

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques