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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01174615
• Other study ID #: UM200901
• Status: Recruiting
• Start date: September 2009
• Est. completion date: December 2100

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: Jan Cerny, MD, PhD
• Phone: 774-442-3903
• Email: Jan.Cerny[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2100
• Est. primary completion date: December 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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