Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
NCT ID: NCT03134027
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2017-10-19
2018-05-09
Brief Summary
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The secondary objective is to use patient tumor biopsy samples or circulating tumor cell samples to develop additional preclinical models of GU cancers, particularly prostate cancer, that are clinically relevant by generating additional PDXs.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects from which PDXs have been generated.
Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
Subjects without an existing PDX
Subjects with prostate cancer amenable to a tumor biopsy.
Tumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
Interventions
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Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
Tumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
Eligibility Criteria
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Inclusion Criteria
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)
6. Karnofsky performance status \>70%
1. Patients with prostate cancer
a. Biopsies in this study for diseases other than prostate cancer are not permitted.
2. Age ≥ 18 years.
3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
4. Planned or willing to undergo a tumor biopsy. Biopsies may be for research or clinical purposes depending on the treating provider for men with prostate cancer. Biopsies in this study for diseases other than prostate cancer are not permitted
1. For research only biopsies: At least one lymph node or bone metastatic amenable to a minimum risk biopsy in the opinion of the treating physician.
2. For clinical purpose biopsies: There are no location or risk requirements.
5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 X 10\^6/l and WBC 4000 X 10\^6/l)
6. Karnofsky performance status \>70%
Exclusion Criteria
1\. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Andrew Armstrong, MD, ScM
Role: PRINCIPAL_INVESTIGATOR
Duke Cancer Institute
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00082398
Identifier Type: -
Identifier Source: org_study_id
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