Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 263.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 263.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 263.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\20729254
.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Clin+Trials
2010 ; 7
(6
): 686-95
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Cancer registries: a novel alternative to long-term clinical trial follow-up
based on results of a comparative study
#MMPMID20729254
Shi Q
; You YN
; Nelson H
; Allen MS
; Winchester D
; Stewart A
; Young-Fadok T
; Decker PA
; Green EM
; Holton SJ
; Ballman KV
Clin Trials
2010[Dec]; 7
(6
): 686-95
PMID20729254
show ga
BACKGROUND: Data collection and review were identified as major contributors to
the cost of randomized clinical trials (RCTs). PURPOSE: We proposed and assessed
a novel alternative for long-term clinical trial follow-up based on the data
captured through an accredited Cancer Registry (CR) that is part of the National
Cancer Database (NCDB). METHODS: Patients from Mayo Clinic, Rochester, enrolled
in the North Central Cancer Treatment Group N934653 (COST) trial (98 patients)
and the American College of Surgeons Oncology Group Z0030 trial (55 patients)
were included in the study. Demographic, treatment, and long-term outcome data
were compared between the hospital-based CR and the RCTs' databases. Concordances
were used to estimate the agreement between two databases. Kaplan-Meier curves
were plotted to examine the consistency of time-to-event long-term outcomes of
the CR and RCT databases. RESULTS: High concordances (>95%) were observed for
most demographic and treatment variables between the CR data and RCT data. The
vital status concordances were 100% and 94.5% between the CR and COST and Z0030
databases, respectively. Three discrepant death dates were observed, one in the
COST trial and two in the Z0030 trial. The concordances of disease-free status
between the CR and RCT databases were 99.0% and 87.3%, and 15 discrepant disease
recurrence cases were identified: 4 for COST and 11 for Z0030. LIMITATIONS: The
analysis has been focused on patients from a single site, Mayo Clinic, Rochester,
enrolled in two large RCT evaluating surgical treatments. The findings herein
need to be confirmed in a broader setting, such as multi-center, multi-registry
including nonsurgical trials. CONCLUSIONS: CR data were nearly identical to data
from two randomized phase III trials in different disease types and conducted by
two different cooperative groups. The NCDB Cancer Registries represent a feasible
alternative for obtaining long-term follow-up data for large clinical trials.
|Colectomy/statistics & numerical data
[MESH]
|Colonoscopy/statistics & numerical data
[MESH]
|Colorectal Neoplasms/*mortality/surgery
[MESH]
|Confidence Intervals
[MESH]
|Data Collection/methods
[MESH]
|Databases as Topic
[MESH]
|Humans
[MESH]
|Kaplan-Meier Estimate
[MESH]
|Neoplasm Recurrence, Local
[MESH]
|Proportional Hazards Models
[MESH]
|Randomized Controlled Trials as Topic/*methods
[MESH]