Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hematology Biobank : Invitro Study of Blood Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02442011
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Henny Billett, Albert Einstein College of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a bio repository of blood specimens from subjects with different Hematological disorders.

Condition or disease
Hematological Disorders

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. We propose 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 us 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hematology Biobank : Invitro Study of Blood Disorders
Study Start Date : January 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Biobank [ Time Frame: 5 years ]
    To have specimens available for IRB approved studies


Biospecimen Retention:   Samples With DNA
Whole blood samples will be processed fresh or frozen and stored in cryo vials at -80°C for future isolation of DNA. DNA isolation will be done using commercially available kits such as Applied Biosystems' "DNA Isolation from Fresh and Frozen Blood, Tissue Culture" http://tools.lifetechnologies.com/content/sfs/manuals/cms_041387.pdf Plasma needed for biomarkers analysis we be obtained from whole blood samples. Whole blood will be spun down, plasma and sediment will be separated and stored in cryo vials at -80°C. Red cells and platelets will be stored at 4C. Red cell hemolysate may be stored at 4C or stored in cryo vials.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects >18 years of age and able to consent
Criteria

Inclusion Criteria:

Above 18 years of age and able to consent

Exclusion Criteria:

None

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02442011


Contacts
Layout table for location contacts
Contact: Swati Goel 7189204137 swgoel@montefiore.org

Locations
Layout table for location information
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Swati Goel    718-920-4137      
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Henny Billett Albert Einstein College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Henny Billett, Chief, Division of Hematology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02442011    
Other Study ID Numbers: 2013-2918
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will enter our deidentified data into REDCap which will make it available to others.
Keywords provided by Henny Billett, Albert Einstein College of Medicine:
Hematology Biobank
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Diseases