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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). 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.
Primary Outcome
Increase in number of cancer cells in patient's blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).
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 |
Why NCT00819832 stopped before completion
NCT00819832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Vertebroplasty is the first listed.
NCT00819832 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00819832's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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