Clinical trial NCT01174615: Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leukemia
Keywords: Blood/bone marrow collection, hematologic diseases, leukemia
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: The study is designed to collect blood and bone marrow from patients with various hematological diseases.
timeFrame: On average, indefinite, or until death of participant
Secondary outcomes:
measure: Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth in Patients With Malignancy or Hematologic Disorders
timeFrame: On average, indefinite, or until death of participant
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Jan Cerny, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: