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

May 24, 2010
March 7, 2014
September 2009
December 2099   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01174615 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Tissue/cells from patients' samples.

Non-Probability Sample

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

Leukemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2100
December 2099   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jan Cerny, MD, PhD 774-442-3903 Jan.Cerny@umassmemorial.org
Contact: Alan Rosmarin, MD 774-443-7433 Alan.Rosmarin@umassmed.edu
United States
 
NCT01174615
UM200901
No
Jan Cerny, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Jan Cerny, MD, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP