Hematology Biobank: In Vitro Study of Blood Disorders | NCT02442011

Studies
Hematology Biobank: In Vitro Study of Blood Disorders

NCT02442011

Sponsor

Albert Einstein College of Medicine

Status

Recruiting

Last Update Posted

Jan 6, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Hematological Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

May 7, 2015

First Submission Date that Met QC Criteria

May 8, 2015

First Posted Date

May 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2026

Last Update Posted Date

Jan 6, 2026Actual

Name	Class
New York Blood Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a biorepository of blood specimens from subjects with different 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biobank	To have specimens available for IRB approved studies	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

- Adult and pediatric patients 12 years of age and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Swati Goel	Contact	7189204137		swgoel@montefiore.org

Overall Officials

Name	Affiliation	Role
Henny Billett	Albert Einstein College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center	Recruiting	The Bronx	New York	10467	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.