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NCT03134027 · ClinicalTrials.gov registry record
Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
A clinical trial, sponsored by Duke University.
- Terminated
- Registry status
- 3
- Enrollment target
NCT03134027: Clinical Trial study, sponsored by Duke University.
NCT03134027 is a clinical trial that was terminated before completion, run by Duke University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03134027 was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.
Interventions
- PROCEDURE Tumor biopsy
- PROCEDURE Bone marrow biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2018-05-09 |
Why NCT03134027 stopped before completion
NCT03134027 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Tumor biopsy is the first listed.
NCT03134027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03134027 about?
NCT03134027 is a clinical study titled "Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers". 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 n...
What is the current status of trial NCT03134027?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2017-10-19. Estimated completion is 2018-05-09.
What interventions are being tested in trial NCT03134027?
The interventions under investigation include: Tumor biopsy (PROCEDURE), Bone marrow biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03134027?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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