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Castleman Disease Collaborative Network Biobank ("Castlebank")

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ClinicalTrials.gov Identifier: NCT02871050
Recruitment Status : Withdrawn (An alternative Biobank Project was initiated.)
First Posted : August 18, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Castleman Disease Collaborative Network

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.

Condition or disease Intervention/treatment
Castleman Disease Castleman's Disease Giant Lymph Node Hyperplasia Angiofollicular Lymph Hyperplasia Angiofollicular Lymph Node Hyperplasia Angiofollicular Lymphoid Hyperplasia GLNH Hyperplasia Giant Lymph Node Other: Sample Collection

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Castleman Disease Collaborative Network Biobank: A Collection of Biospecimens and Clinical Data to Facilitate Research
Study Start Date : June 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


Group/Cohort Intervention/treatment
Castleman Disease Patients
Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease.
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.




Primary Outcome Measures :
  1. Samples Collected [ Time Frame: 3 years ]
    Number of samples collected across different subgroups (e.g. blood products, lymph node)


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Castleman Disease patients worldwide
Criteria

Inclusion Criteria

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

Exclusion Criteria

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871050


Locations
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United States, Pennsylvania
Castleman Disease Collaborative Network
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
Castleman Disease Collaborative Network
Investigators
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Principal Investigator: David C Fajgenbaum, MD, MBA, MSc Executive Director of Castleman Disease Collaborative Network

Additional Information:
Publications:
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Responsible Party: Castleman Disease Collaborative Network
ClinicalTrials.gov Identifier: NCT02871050     History of Changes
Other Study ID Numbers: #31132/1
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by Castleman Disease Collaborative Network:
Biobank
biorepository
Castlebank
Castleman Disease
CD
MCD
iMCD
Castleman
Castleman's Disease
multicentric Castleman's disease
multicentric Castleman disease
Angiofollicular Lymph Hyperplasia

Additional relevant MeSH terms:
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Hyperplasia
Castleman Disease
Lymphadenopathy
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases