Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
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|ClinicalTrials.gov Identifier: NCT01174615|
Recruitment Status : Recruiting
First Posted : August 3, 2010
Last Update Posted : May 12, 2023
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|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- 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.
- 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
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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|
- 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.
- 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
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
|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|
|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|
|Principal Investigator:||Jan Cerny, MD, PhD||University of Massachusetts, Worcester|
|Responsible Party:||Jan Cerny, Principal Investigator, University of Massachusetts, Worcester|
|Other Study ID Numbers:||
|First Posted:||August 3, 2010 Key Record Dates|
|Last Update Posted:||May 12, 2023|
|Last Verified:||May 2023|
Blood/bone marrow collection, hematologic diseases, leukemia
Neoplasms by Histologic Type