LeukemiaNCT01174615
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth
An observational study of Leukemia, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2100
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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
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.
- Conditions
- Leukemia
- Keywords
- Blood/bone marrow collection, hematologic diseases, leukemia
- Medical subject headings
- Leukemia, Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On average, indefinite, or until death of participant
Secondary outcomes (1)
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.
Measured: On average, indefinite, or until death of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2099 (estimated)
- Study completionDec 2100 (estimated)
Why it stopped: Withdrawing as this is not a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Cerny, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174615
- Sponsor's protocol ID
- UM200901
- Status last verified
- Sep 2024
- First submitted
- 24 May 2010
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01174615
- Acronym / sponsor ID
- UM200901
- Conditions
- Leukemia
- Keywords
- Blood/bone marrow collection, hematologic diseases, leukemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawing as this is not a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2099 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Cerny, MD, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.