Prospective Bone Marrow Biopsy Safety and Efficacy Study

August 13, 2015 updated by: Weijuan Li, Jacobi Medical Center

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:

  1. 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.
  2. The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult hematology patients who have just completed an elective bone marrow biopsy will be considered eligible for enrollment.

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects must be 40 years of age or older.

Exclusion Criteria:

  1. Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
  2. Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
  3. Patients with uncontrolled bleeding disorders.
  4. Pregnant and lactating females (due to radiation exposure during the CT scans).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days after the bone marrow biopsy
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
5 days after the bone marrow biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-4653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Marrow

Clinical Trials on Pelvis CT scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe