Castleman Disease Collaborative Network Biobank ("Castlebank")

July 28, 2018 updated by: Castleman Disease Collaborative Network

The Castleman Disease Collaborative Network Biobank: A Collection of Biospecimens and Clinical Data to Facilitate Research

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Castleman Disease Collaborative Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Castleman Disease patients worldwide

Description

Inclusion Criteria

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

Exclusion Criteria

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castleman Disease Collaborative Network

Investigators

  • Principal Investigator: David C Fajgenbaum, MD, MBA, MSc, Executive Director of Castleman Disease Collaborative Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #31132/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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