Trial Outcomes & Findings for Anderson Circulating Tumor Cell Burden (CTCB) Study (NCT NCT00819832)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)

Results posted on

2023-03-24

Participant Flow

Recruitment Period: December 30, 2008 to March 29, 2010. All recruitment done at UT MD Anderson Cancer Center.

Study terminated by sponsor. No patient data analysis performed due to the limited amount of data gathered from the study's three participants.

Participant milestones

Participant milestones
Measure	Phase 1 Group 1 Vertebroplasty Vertebroplasty	Phase 1 Group 2 Kyphoplasty Kyphoplasty	Phase 2 Group 1 Vertebroplasty Vertebroplasty	Phase 2 Group 2 Vertebroplasty +Cavity SpineWand Vertebroplasty with Cavity SpineWand	Phase 2 Group 3 Kyphoplasty Kyphoplasty	Phase 2 Group 4 Kyphoplasty + Cavity SpineWand Kyphoplasty with Cavity SpineWand
Overall Study STARTED	3	0	0	0	0	0
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Group 1 Vertebroplasty Vertebroplasty	Phase 1 Group 2 Kyphoplasty Kyphoplasty	Phase 2 Group 1 Vertebroplasty Vertebroplasty	Phase 2 Group 2 Vertebroplasty +Cavity SpineWand Vertebroplasty with Cavity SpineWand	Phase 2 Group 3 Kyphoplasty Kyphoplasty	Phase 2 Group 4 Kyphoplasty + Cavity SpineWand Kyphoplasty with Cavity SpineWand
Overall Study Sponsor Termination of Study	3	0	0	0	0	0

Baseline Characteristics

Anderson Circulating Tumor Cell Burden (CTCB) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Group 1 Vertebroplasty n=3 Participants Vertebroplasty	Phase 1 Group 2 Kyphoplasty Kyphoplasty	Phase 2 Group 1 Vertebroplasty Vertebroplasty	Phase 2 Group 2 Vertebroplasty +Cavity SpineWand Vertebroplasty with Cavity SpineWand	Phase 2 Group 3 Kyphoplasty Kyphoplasty	Phase 2 Group 4 Kyphoplasty + Cavity SpineWand Kyphoplasty with Cavity SpineWand	Total n=3 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	—	—	—	—	—	63 years n=115 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	—	—	—	—	—	3 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=115 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	—	—	—	—	3 participants n=115 Participants

PRIMARY outcome

Timeframe: Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)

Population: Study terminated by sponsor; No data analysis done on limited amount of data gathered.

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Dawid Schellingerhout, MD/Asst. Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place