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Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth

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: NCT01174615
Recruitment Status : Recruiting
First Posted : August 3, 2010
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Jan Cerny, University of Massachusetts, Worcester

Study Description
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Brief Summary:
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 or disease
Leukemia

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
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
Study Start Date : September 2009
Estimated Primary Completion Date : December 2099
Estimated Study Completion Date : December 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

Eligibility Criteria
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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
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
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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): NCT01174615


Contacts
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Contact: Jan Cerny, MD, PhD 774-442-3903 Jan.Cerny@umassmemorial.org
Contact: Jacqueline Wheeler, RN, BSN, OCN 774-455-4478 Jacqueline.Wheeler@umassmed.edu

Locations
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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: Karl Simin, PhD    508-856-3959    Karl.Simin@umassmed.edu   
Principal Investigator: Jan Cerny, MD, PhD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Jan Cerny, MD, PhD University of Massachusetts, Worcester
More Information
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Responsible Party: Jan Cerny, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01174615    
Other Study ID Numbers: UM200901
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Keywords provided by Jan Cerny, University of Massachusetts, Worcester:
Blood/bone marrow collection, hematologic diseases, leukemia
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms