- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02442011
Hematology Biobank: In Vitro Study of Blood Disorders
Study Overview
Status
Conditions
Detailed Description
There has been a marked increase in our knowledge of Blood Disorders in the last decade. Much of this knowledge comes from examining blood specimens from patients and subjecting these samples to red cell, plasma, serum or DNA analyses. The study team proposes to set up a Hematology biobank, which will include patient histories, their medical progress and a linked but de-identified bank of blood samples. This will enable researchers to have a large database, which can be used to learn more about these diseases.
The Hematology biobank will use whole blood, red blood cells, plasma, serum and/or DNA. Whole blood specimens, which by definition include the white cells that contain DNA, will be collected and stored in the biobank repository at the Institute for Clinical and Translational Research (ICTR) for future studies.
Blood samples will be obtained from two sources:
- Leftover/discarded whole blood samples that were obtained for standard of care.
- Blood samples consisting of 1-5 tubes (3-20 ml of whole blood) from patients with written consent. When possible, these samples will be obtained during routine blood draws performed for a typical visit. It may be necessary to ask patients to specifically donate blood for the study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Swati Goel
- Phone Number: 7189204137
- Email: swgoel@montefiore.org
Study Locations
-
-
New York
-
The Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center
-
Contact:
- Swati Goel
- Phone Number: 718-920-4137
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Above 12 years of age and referred to the Hematology Division at Montefiore-Einstein
- Under the care of a Montefiore-Einstein hematologist for a hematologic disorder
Exclusion Criteria:
- Do not meet the Inclusion Criteria listed above
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biobank
Time Frame: 5 years
|
To have specimens available for IRB approved studies
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Henny Billett, Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-2918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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