Bone MarrowNCT02524613
Prospective Bone Marrow Biopsy Safety and Efficacy Study
An observational study of Bone Marrow, run by Jacobi Medical Center.
Trial summary
Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bone Marrow
- What is being tested?
- Pelvis CT scan
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to May 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult hematology patients who have just completed an elective bone marrow biopsy will be considered eligible for enrollment.
Who may be able to join
- Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease.
- Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study.
- Subjects must be 40 years of age or older.
Who cannot join
- Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
- Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
- Patients with uncontrolled bleeding disorders.
- Pregnant and lactating females (due to radiation exposure during the CT scans).
About this study
Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals:
- The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training.
- The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.
- Conditions
- Bone Marrow
- Being tested
- Pelvis CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvis CT scanOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates associated with bone marrow biopsy
Complications will be assessed by a modified pelvic CT
Measured: 5 days after the bone marrow biopsy
Quality of bone marrow biopsy
Length of the bone marrow biospy specimen in mm is measured by a pathologist blindly
Measured: 5 days after the bone marrow biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone MarrowStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijuan Li, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524613
- Sponsor's protocol ID
- 2015-4653
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reed LJ, Attarian S, Olson TR, Singh S, Shestopalov A, Friedman EW. Feasibility and safety of targeting the anterior superior iliac spine to perform a bone marrow procedure: a prospective, clinical study. J Clin Pathol. 2018 Dec;71(12):1116-1119. doi: 10.1136/jclinpath-2018-205309. Epub 2018 Oct 23.
PubMed 30352912Attarian S, Reed L, Singh S, Shestopalov A, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Elrafei T, Li W, Yee C, Friedman EW. Visualization of the bone marrow biopsy needle track. Am J Hematol. 2018 Mar;93(3):E60-E61. doi: 10.1002/ajh.24985. Epub 2017 Dec 6. No abstract available.
PubMed 29168229Reed L, Attarian S, Pendurti G, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Moon JY, Kim M, Elrafei T, Alexis K, Strakhan M, Li W, Friedman E. Targeting the anterior superior iliac spine yields significantly longer bone marrow cores. J Clin Pathol. 2018 Feb;71(2):172-173. doi: 10.1136/jclinpath-2017-204686. Epub 2017 Aug 26.
PubMed 28844037
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Bone Marrow Biopsy Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT02524613
- Acronym / sponsor ID
- 2015-4653
- Conditions
- Bone Marrow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jacobi Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 17 Aug 2015 (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.
Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals:
- The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training.
- The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult hematology patients who have just completed an elective bone marrow biopsy will be considered eligible for enrollment.
Key inclusion criteria (3 listed)
- Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease.
- Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study.
- Subjects must be 40 years of age or older.
Key exclusion criteria (4 listed)
- Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
- Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
- Patients with uncontrolled bleeding disorders.
- Pregnant and lactating females (due to radiation exposure during the CT scans).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvis CT scan | Other | – |
Primary outcome
Complication rates associated with bone marrow biopsy
Time frame: 5 days after the bone marrow biopsy
Complications will be assessed by a modified pelvic CT
Quality of bone marrow biopsy
Time frame: 5 days after the bone marrow biopsy
Length of the bone marrow biospy specimen in mm is measured by a pathologist blindly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Derived from this study: PubMed 30352912Reed LJ, Attarian S, Olson TR, Singh S, Shestopalov A, Friedman EW. Feasibility and safety of targeting the anterior superior iliac spine to perform a bone marrow procedure: a prospective, clinical study. J Clin Pathol. 2018 Dec;71(12):1116-1119. doi: 10.1136/jclinpath-2018-205309. Epub 2018 Oct 23.
- Derived from this study: PubMed 29168229Attarian S, Reed L, Singh S, Shestopalov A, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Elrafei T, Li W, Yee C, Friedman EW. Visualization of the bone marrow biopsy needle track. Am J Hematol. 2018 Mar;93(3):E60-E61. doi: 10.1002/ajh.24985. Epub 2017 Dec 6. No abstract available.
- Derived from this study: PubMed 28844037Reed L, Attarian S, Pendurti G, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Moon JY, Kim M, Elrafei T, Alexis K, Strakhan M, Li W, Friedman E. Targeting the anterior superior iliac spine yields significantly longer bone marrow cores. J Clin Pathol. 2018 Feb;71(2):172-173. doi: 10.1136/jclinpath-2017-204686. Epub 2017 Aug 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow, run by Jacobi Medical Center.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Complication rates associated with bone marrow biopsy (time frame: 5 days after the bone marrow biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524613, which also lists 3 linked publications.
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 17 Aug 2015.