Trial record 1 of 1 for:    Collection of Blood and/or Bone Marrow in Patients with Malignancy or Hematologic Disorders
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Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Massachusetts, Worcester
Sponsor:
Information provided by (Responsible Party):
Jan Cerny, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01174615
First received: May 24, 2010
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell malignancies and associated conditions will serve as a convenient and comprehensive source of tissue to give us further information about the differences between normal blood cells and blood cells of affected individuals. This will be an invaluable asset for understanding the biology of blood disorders. The collected samples will be used by investigators for studies including immunology, molecular biology and genetics to name a few.


Condition
Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • The study is designed to collect blood and bone marrow from patients with various hematological diseases. [ Time Frame: On average, indefinite, or until death of participant ] [ Designated as safety issue: No ]
    The study is designed to collect blood and bone marrow from patients with various hematological diseases. The samples will be used for various research studies for better understanding of biology of various blood disorders including hematological malignancies. Relevant clinical and laboratory features and subsequent changes will be noted for correlation with these studies. The tissue/cells will be additionally banked and/or used for other investigations in the future.


Secondary Outcome Measures:
  • Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders [ Time Frame: On average, indefinite, or until death of participant ] [ Designated as safety issue: No ]
    Develop a database of subjects who have donated samples for research as well as tissue banking, some of whom may be contacted again for consideration of additional studies in the future.


Biospecimen Retention:   Samples Without DNA

Tissue/cells from patients' samples.


Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: December 2100
Estimated Primary Completion Date: December 2099 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients over the age of 18 with blood and/or bone disorders (leukemia, myeloproliferative disorders, lymphoma etc.) with alterations of their blood counts.

Criteria

Inclusion Criteria:

  • Selected patients over the age of 18 with hematologic malignancies or other blood disorders (leukemia, myeloproliferative disorders, lymphoma, other malignancies involving the bone marrow or patients with unexplained alterations in their complete blood count).

Patients who are scheduled to undergo a bone marrow aspirate and/or phlebotomy for other clinical indications will be asked to participate. They will be asked to donate an additional small aliquot of bone marrow and/or blood during the course of their already scheduled bone marrow aspiration or phlebotomy.

Exclusion Criteria:

  • Patients with pre-existing medical conditions that might be exacerbated by the procedure of obtaining bone marrow or blood
  • Patients who are allergic to Lidocaine, which is used as a local anesthetic, and who cannot receive a suitable substitute anesthetic.
  • Patients who have a bleeding diathesis which might pose a problem with marrow aspiration.
  • Patients unable to give informed consent.
  • Pregnant patients
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174615

Contacts
Contact: Jan Cerny, MD, PhD 774-442-3903 Jan.Cerny@umassmemorial.org
Contact: Alan Rosmarin, MD 774-443-7433 Alan.Rosmarin@umassmed.edu

Locations
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Jan Cerny, MD, PhD    774-442-3903    Jan.Cerny@umassmemorial.org   
Contact: Stephen Lyle, MD, PhD    508-856-4774    Stephen.Lyle@umassmed.edu   
Principal Investigator: Jan Cerny, MD, PhD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Jan Cerny, MD, PhD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Jan Cerny, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01174615     History of Changes
Other Study ID Numbers: UM200901
Study First Received: May 24, 2010
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Blood/bone marrow collection, hematologic diseases, leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014