Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples

This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and blood specimens to be collected for research purposes, specifically allowing subjects the option of sedation during the bone marrow procedure. Samples will be banked for future research related to cancer and other diseases. Researchers hope this protocol will improve the collection of research correlative and translational biopsy specimens for clinical research.

Study Overview

• Status: Recruiting
• Conditions: No Restrictions on Diagnosis
• Intervention / Treatment: Other: Obtaining human tissue for basic research or biospecimen bank

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Dan Vogl, MD; Phone Number: 855-216-0098; Email: PennCancerTrials@emergingmed.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania
      • Principal Investigator: Dan Vogl, MD
      • Contact: Dan Vogl, MD; Phone Number: 855-216-0098; Email: PennCancerTrials@emergingmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and females, 18 years of age and older who are scheduled to undergo a bone marrow aspirate and/or bone marrow biopsy as part of their participation on another research study, who are allowing their samples to be collected and used for research purposes, and/or who might benefit from the administration of moderate sedation. Therefore, there are no restrictions with regards to diagnosis, though most patients will have hematologic malignancies (leukemia, lymphoma, myeloma, amyloidosis, myelodysplastic syndromes, myeloproliferative diseases).

Description

Inclusion Criteria:

• Planned procedure including a bone marrow aspirate and/or bone marrow biopsy
• The procedure is planned for the purpose of obtaining a research specimen (as part of another research study or as part of this stand-alone sample collection protocol.). Procedures with a dual purpose (i.e. to obtain both clinically-indicated specimens and research specimens) are permitted, but procedures to obtain clinical specimens only are not permitted.
• All subjects must provide written informed consent for the biopsy procedure, the collection of bone marrow and blood specimens for research purposes and (if planned) the administration of sedation.

Exclusion Criteria:

• Moderate sedation may not be administrated to subjects with a clinical contraindication to its provision, or if the investigator believes that administration of moderate sedation would constitute under risk to the subject.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bone marrow aspirate/biopsy and blood specimens; Collection of blood and bone marrow specimens for research purposes and increase the successful acquisition of correlative bone marrow samples to improve translational research in bone marrow diseases	Other: Obtaining human tissue for basic research or biospecimen bank

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	2 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Dan Vogl, MD, Abramson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Anticipated): May 7, 2025
• Study Completion (Anticipated): May 7, 2025

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimate): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: UPCC 01709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No