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NCT00819832 · ClinicalTrials.gov registry record · Phase 4
Anderson Circulating Tumor Cell Burden (CTCB) Study
A Phase 4 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT00819832: Clinical Trial Phase 4 study, sponsored by M.D. Anderson Cancer Center.
NCT00819832 is a Phase 4 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819832, a Phase 4 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Phase 1 - Optimization Phase: Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB. Phase 2 - Comparison Phase: Primary Objective: The primary objective of Phase 2 of this study is to determine the change in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to compare the average change between treatment groups with and without the use of the Cavity SpineWand. Secondary Objectives: * To determine the change in self-reported pain level from baseline to post-treatment as measured using the visual analogue scale (VAS) for spine pain and to compare the average change in pain level between treatment groups. * To determine the change in pain status from baseline to post-treatment as measured using the Brief Pain Inventory (BPI) and to compare the average change in pain status between treatment groups. * To determine the change from baseline to post-treatment in the M.D. Anderson Cancer Center Symptom Inventory (MDASI) and to compare the average change between treatment groups. * To determine the change from baseline to post-treatment in time to walk a 50-foot distance and to compare the average change between treatment groups.
Interventions
- PROCEDURE Vertebroplasty
- PROCEDURE Kyphoplasty
- DEVICE Cavity SpineWand
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00819832
The ClinicalTrials.gov registry entry for NCT00819832 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vertebroplasty is the first listed.
NCT00819832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00819832 about?
NCT00819832 is a clinical study titled "Anderson Circulating Tumor Cell Burden (CTCB) Study". Phase 1 - Optimization Phase: Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB. Phase 2 - Comparison P...
What is the current status of trial NCT00819832?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2008-12. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00819832?
The interventions under investigation include: Vertebroplasty (PROCEDURE), Kyphoplasty (PROCEDURE), Cavity SpineWand (DEVICE).
Who is sponsoring clinical trial NCT00819832?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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