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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02871050
Other study ID # #31132/1
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2018

Study information

Verified date July 2018
Source Castleman Disease Collaborative Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria

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

Exclusion Criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sample Collection
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.

Locations

Country Name City State
United States Castleman Disease Collaborative Network Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Castleman Disease Collaborative Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

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