Castleman Disease"Castlebank"NCT02871050
Castleman Disease Collaborative Network Biobank
An observational study of Castleman Disease and Castleman's Disease, run by Castleman Disease Collaborative Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Castleman Disease, Castleman's Disease, Giant Lymph Node Hyperplasia
- What is being tested?
- Sample Collection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Castleman Disease patients worldwide
Who may be able to join
- Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Castleman Disease Collaborative Network
Philadelphia, Pennsylvania, 19146
About this study
Official title: 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.
Read the 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
- Castleman Disease, Castleman's Disease, Giant Lymph Node Hyperplasia, Angiofollicular Lymph Hyperplasia, Angiofollicular Lymph Node Hyperplasia, Angiofollicular Lymphoid Hyperplasia
- Being tested
- Sample Collection
- Keywords
- Biobank, biorepository, Castlebank, Castleman Disease, CD, MCD, iMCD, Castleman, Castleman's Disease, multicentric Castleman's disease, multicentric Castleman disease, Angiofollicular Lymph Hyperplasia
- Medical subject headings
- Castleman Disease, Hyperplasia, Macular dystrophy, corneal type 1, Multi-centric Castleman's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Castleman Disease Patients | Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease. Receives: Other: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Samples Collected
Number of samples collected across different subgroups (e.g. blood products, lymph node)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: An alternative Biobank Project was initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Castleman DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castleman Disease Collaborative Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C Fajgenbaum, MD, MBA, MSc, Principal investigator, Executive Director of Castleman Disease Collaborative Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871050
- Sponsor's protocol ID
- #31132/1
- Acronym
- "Castlebank"
- Status last verified
- Jul 2018
- First submitted
- 15 Aug 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27063975Fajgenbaum 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.
PubMed 24622327
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Castleman Disease Collaborative Network Biobank: A Collection of Biospecimens and Clinical Data to Facilitate Research
- ClinicalTrials.gov ID
- NCT02871050
- Acronym / sponsor ID
- "Castlebank" / #31132/1
- Conditions
- Castleman Disease, Castleman's Disease, Giant Lymph Node Hyperplasia, Angiofollicular Lymph Hyperplasia, Angiofollicular Lymph Node Hyperplasia, Angiofollicular Lymphoid Hyperplasia
- Keywords
- Biobank, biorepository, Castlebank, Castleman Disease, CD, MCD, iMCD, Castleman
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: An alternative Biobank Project was initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Castleman Disease Collaborative NetworkUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Castleman Disease Patients | – | Other: Sample CollectionPotential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Castleman Disease patients worldwide
Key inclusion criteria (1 listed)
- Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample CollectionExcess 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. | Other | Castleman Disease Patients |
Primary outcome
Samples Collected
Time frame: 3 years
Number of samples collected across different subgroups (e.g. blood products, lymph node)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Background: PubMed 27063975Liu 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.
- Background: PubMed 24622327Fajgenbaum 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.
- website includes information on Castleman DiseaseLink provided by the sponsor.
- Please visit this link to sign-up and contribute samples!Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Castleman Disease
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Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
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Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Fajgenbaum, MD, MBA, MSc principal investigator
Executive Director of Castleman Disease Collaborative Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castleman Disease and Castleman's Disease, run by Castleman Disease Collaborative Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Samples Collected (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.