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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00308 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Winship2656-14 | Other Identifier | Emory University/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available.
Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system.
100 participants will be enrolled in this study at Emory University.
PRIMARY OBJECTIVE:
I. Assessing the quality and quantity of bone marrow core biopsies.
SECONDARY OBJECTIVES:
I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires.
II. Timing of the actual procedure.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bone marrow biopsy using the power drill.
ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle.
All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (biopsy using power drill) | Experimental | Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. |
|
| Arm II (biopsy using Jamshidi needle) | Active Comparator | Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power drill | Device | Undergo bone marrow biopsy using power drill |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist | Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test. | At the time of biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain. | At the time of, 30 minutes, 1, 3, and 7 days after biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Nooka, MD, MPH | Emory University/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Biopsy Using Power Drill) | Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Power drill: Undergo bone marrow biopsy using power drill |
| FG001 | Arm II (Biopsy Using Jamshidi Needle) | Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Biopsy Using Power Drill) | Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Power drill: Undergo bone marrow biopsy using power drill |
| BG001 | Arm II (Biopsy Using Jamshidi Needle) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist | Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test. | Posted | Mean | 95% Confidence Interval | Millimeters | At the time of biopsy |
|
Collected for each patient through day +7 after enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Biopsy Using Power Drill) | Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Power drill: Undergo bone marrow biopsy using power drill |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ajay Nooka | Emory University | 404-778-1900 | anooka@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2015 | Apr 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2022 | Apr 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Jamshidi needle |
| Device |
Undergo bone marrow biopsy using Jamshidi needle |
|
| Time Taken by the Procedure Measured in Seconds Using a Stopwatch | Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test. | At the time of biopsy |
Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Prior Bone Marrow Aspiration & Biopsies (BMA&B) within the last 2 years | Count of Participants | Participants |
|
|
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| Secondary | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain. | Posted | Mean | 95% Confidence Interval | score on a scale | At the time of, 30 minutes, 1, 3, and 7 days after biopsy |
|
|
|
| Secondary | Time Taken by the Procedure Measured in Seconds Using a Stopwatch | Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test. | Posted | Mean | 95% Confidence Interval | Seconds | At the time of biopsy |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Arm II (Biopsy Using Jamshidi Needle) | Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle | 0 | 50 | 0 | 50 | 0 | 50 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| 3 days after biopsy |
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| 7 days after biopsy |
|