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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jan Cerny, MD, PhD; Phone Number: 774-442-3903; Email: Jan.Cerny@umassmemorial.org
• Study Contact Backup: Name: Jacqueline Wheeler, RN, BSN, OCN; Phone Number: 774-455-4478; Email: Jacqueline.Wheeler@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Medical School
      • Contact: Jan Cerny, MD, PhD; Phone Number: 774-442-3903; Email: Jan.Cerny@umassmemorial.org
      • Contact: Karl Simin, PhD; Phone Number: 508-856-3959; Email: Karl.Simin@umassmed.edu
      • Principal Investigator: Jan Cerny, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The study is designed to collect blood and bone marrow from patients with various hematological diseases.	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.	On average, indefinite, or until death of participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders	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.	On average, indefinite, or until death of participant

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Jan Cerny, MD, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2099
• Study Completion (Anticipated): December 1, 2100

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Blood/bone marrow collection, hematologic diseases, leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: UM200901