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Trial record 59 of 1830 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT01985919
Recruitment Status : Recruiting
First Posted : November 18, 2013
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment
No Restrictions on Diagnosis Other: Obtaining human tissue for basic research or biospecimen bank

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : May 7, 2021
Estimated Study Completion Date : May 7, 2021

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



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985919


Contacts
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Contact: Dan Vogl, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dan Vogl, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Dan Vogl, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Dan Vogl, MD Abramson Cancer Center

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01985919     History of Changes
Other Study ID Numbers: UPCC 01709
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No