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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: No Restrictions on Diagnosis

Treatments: Other: Obtaining human tissue for basic research or biospecimen bank

Study type: Observational

Funder types: Other

Identifiers

NCT01985919

UPCC 01709

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Bone marrow aspirate/biopsy and blood specimens

Description:

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

Treatment:

Other: Obtaining human tissue for basic research or biospecimen bank