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

NCT01985919 | Completed DMC

• 1 other identifier: UPCC 01709
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

No Restrictions on Diagnosis

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  2 years

Study Arms (1)

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

Interventions

Obtaining human tissue for basic research or biospecimen bank OTHER

Bone marrow aspirate/biopsy and blood specimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Dan Vogl, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: February 1, 2010
• Primary Completion: June 13, 2025
• Study Completion: July 14, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (1)