Determination of Clinical Utility of Tumor Markers: A Tumor Marker Utility Grading System

Author(s):  
D. F. Hayes
1996 ◽  
Vol 88 (20) ◽  
pp. 1456-1466 ◽  
Author(s):  
D. F. Hayes ◽  
R. C. Bast ◽  
C. E. Desch ◽  
H. Fritsche ◽  
N. E. Kemeny ◽  
...  

2012 ◽  
Vol 30 (34) ◽  
pp. 4223-4232 ◽  
Author(s):  
Lisa M. McShane ◽  
Daniel F. Hayes

Clinical management decisions for patients with cancer are increasingly being guided by prognostic and predictive markers. Use of these markers should be based on a sufficiently comprehensive body of unbiased evidence to establish that benefits to patients outweigh harms and to justify expenditure of health care dollars. Careful assessments of the clinical utility of markers by using comparative effectiveness research methods are urgently needed to more rigorously summarize and evaluate the evidence, but multiple factors have made such assessments difficult. The literature on tumor markers is plagued by nonpublication bias, selective reporting, and incomplete reporting. Several measures to address these problems are discussed, including development of a tumor marker study registry, greater attention to assay analytic performance and specimen quality, use of more rigorous study designs and analysis plans to establish clinical utility, and adherence to higher standards for reporting tumor marker studies. More complete and transparent reporting by adhering to criteria such as BRISQ [Biospecimen Reporting for Improved Study Quality] criteria for reporting details about specimens and REMARK [Reporting Recommendations for Tumor Marker Prognostic Studies] criteria for reporting a multitude of aspects relating to study design, analysis, and results, is essential for reliable assessment of study quality, detection of potential biases, and proper interpretation of study findings. Adopting these measures will improve the quality of the body of evidence available for comparative effectiveness research and enhance the ability to establish the clinical utility of prognostic and predictive tumor markers.


1999 ◽  
Vol 14 (2) ◽  
pp. 99-105 ◽  
Author(s):  
T. Yoshimasu ◽  
S. Maebeya ◽  
T. Suzuma ◽  
T. Bessho ◽  
H. Tanino ◽  
...  

Determination of the standard elimination kinetics of tumor markers will be helpful in the diagnosis of malignancies. We analyzed the disappearance curves for serum tumor marker levels after resection of intrathoracic malignancies. Serum levels of CEA, SLX, AFP, CA 19-9, SCC, TPA and CYFRA were measured several times after surgery in a total of 40 patients. To obtain precise biological half-lives, we applied non-linear least square analysis, taking into consideration the possibility of residual tumor cells. Disappearance curves were monophasic for CEA, SCC, TPA, CYFRA and SLX and biphasic for CA 19-9 and AFP. Temporary elevation of serum levels after surgery was observed for SCC, TPA and CYFRA. The average half-lives of CEA, SLX, SCC, TPA and CYFRA were 1.5 days, 2.7 days, 2.2 hours, 2.5 hours and 1.5 hours, respectively. The average half-life of CA 19-9 was 0.5 days in the first compartment and 4.3 days in the second compartment, while that of AFP was 1.0 days and 6.3 days, respectively. These values will be helpful in the interpretation of serum tumor marker levels after surgery.


1996 ◽  
Vol 11 (1) ◽  
pp. 40-45 ◽  
Author(s):  
X. Filella ◽  
A.M. Ballesta ◽  
M. Fox ◽  
H. Mitchell ◽  
R. Molina ◽  
...  

The aim of our study was to evaluate the clinical usefulness of the tumor markers CEA, CA 125 and PSA using the COBAS CORE system from Roche Diagnostic Systems. Our results demonstrate that determination of these markers on the COBAS CORE immunoassasy analyser provides the performance required for routine use in clinical practice. The results obtained in this clinical trial validate the correlation with disease extension, a characteristic that defines and determines the clinical utility of the tumor markers. We also conclude that learning to operate the COBAS CORE system is simple, as is management of the system through the user-friendly software.


1997 ◽  
Vol 107 (1) ◽  
pp. 12-19 ◽  
Author(s):  
Richard W. Brown ◽  
Lauri Brozo Campagna ◽  
J. Kay Dunn ◽  
Philip T. Cagle

2002 ◽  
Vol 126 (12) ◽  
pp. 1518-1526 ◽  
Author(s):  
Alex J. Rai ◽  
Zhen Zhang ◽  
Jason Rosenzweig ◽  
Ie-ming Shih ◽  
Thang Pham ◽  
...  

Abstract Context.—Current tumor markers for ovarian cancer still lack adequate sensitivity and specificity to be applicable in large populations. High-throughput proteomic profiling and bioinformatics tools allow for the rapid screening of a large number of potential biomarkers in serum, plasma, or other body fluids. Objective.—To determine whether protein profiles of plasma can be used to identify potential biomarkers that improve the detection of ovarian cancer. Design.—We analyzed plasma samples that had been collected between 1998 and 2001 from patients with sporadic ovarian serous neoplasms before tumor resection at various International Federation of Gynecology and Obstetrics stages (stage I [n = 11], stage II [n = 3], and stage III [n = 29]) and from women without known neoplastic disease (n = 38) using proteomic profiling and bioinformatics. We compared results between the patients with and without cancer and evaluated their discriminatory performance against that of the cancer antigen 125 (CA125) tumor marker. Results.—We selected 7 biomarkers based on their collective contribution to the separation of the 2 patient groups. Among them, we further purified and subsequently identified 3 biomarkers. Individually, the biomarkers did not perform better than CA125. However, a combination of 4 of the biomarkers significantly improved performance (P ≤ .001). The new biomarkers were complementary to CA125. At a fixed specificity of 94%, an index combining 2 of the biomarkers and CA125 achieves a sensitivity of 94% (95% confidence interval, 85%–100.0%) in contrast to a sensitivity of 81% (95% confidence interval, 68%–95%) for CA125 alone. Conclusions.—The combined use of bioinformatics tools and proteomic profiling provides an effective approach to screen for potential tumor markers. Comparison of plasma profiles from patients with and without known ovarian cancer uncovered a panel of potential biomarkers for detection of ovarian cancer with discriminatory power complementary to that of CA125. Additional studies are required to further validate these biomarkers.


2015 ◽  
Vol 29 (4) ◽  
pp. 441-445 ◽  
Author(s):  
Mary J. Sandage ◽  
Laura W. Plexico ◽  
Amy Schiwitz

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