Trial record 1 of 1 for:
Collection of Blood and/or Bone Marrow in Patients with Malignancy or Hematologic Disorders
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
This study is currently recruiting participants.
Verified February 2013 by University of Massachusetts, Worcester
Sponsor:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Jan Cerny, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01174615
First received: May 24, 2010
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
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 |
|---|
|
Leukemia |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Massachusetts, Worcester:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
Biospecimen Retention: Samples Without DNA
Tissue/cells from patients' samples.
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2100 |
| Estimated Primary Completion Date: | December 2099 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174615
Contacts
| Contact: Jan Cerny, MD, PhD | 774-442-3903 | Jan.Cerny@umassmemorial.org |
| Contact: Alan Rosmarin, MD | 774-443-7433 | Alan.Rosmarin@umassmed.edu |
Locations
| 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: Stephen Lyle, MD, PhD 508-856-4774 Stephen.Lyle@umassmed.edu | |
| Principal Investigator: Jan Cerny, MD, PhD | |
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
| Principal Investigator: | Jan Cerny, MD, PhD | University of Massachusetts, Worcester |
More Information
No publications provided
| Responsible Party: | Jan Cerny, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01174615 History of Changes |
| Other Study ID Numbers: | UM200901 |
| Study First Received: | May 24, 2010 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
Blood/bone marrow collection, hematologic diseases, leukemia |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013