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Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers (Immune PDX)

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ClinicalTrials.gov Identifier: NCT03134027
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the host immune system will not be observed and therefore a preclinical model to study immunotherapy can be developed to study, understand and improve upon our current therapies. HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.

Condition or disease Intervention/treatment
Genito Urinary Cancer Bladder Cancer Kidney Cancer Prostate Cancer Procedure: Bone marrow biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects from which PDXs have been generated.
Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
 Procedure: Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.


Outcome Measures
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Primary Outcome Measures :
  1. Reconstitution of a matched human immune system in patient derived xenografts (PDXs) [ Time Frame: approximately 4 months ]
    Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.


Eligibility Criteria
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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:   Non-Probability Sample
Study Population
Duke Cancer Institute Patients
Criteria

Inclusion Criteria:

  1. Patients with Genitourinary (GU) Cancers and presence of existing patient derived xenograft or planned collection of tumor for PDX generation
  2. Age ≥ 18 years.
  3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
  4. Ability to undergo bone marrow biopsy
  5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 + 10^6/l and WBC 4000 X 10^6/l)

Exclusion Criteria:

1. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.

Contacts and Locations
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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): NCT03134027


Contacts
Contact: Julia Rasmussen, MS, RN, BSN 919-681-1030 julia.rasmussen@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Julia Rasmussen, MS, RN, BSN    919-681-1030    julia.rasmussen@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Shiaowen David Hsu, MD, PhD Duke Cancer Institute
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03134027     History of Changes
Other Study ID Numbers: Pro00082398
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Neoplasms
 Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type