Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors

William J. Ellis, Brent A. Blumenstein, Laura M. Ishak, David L. Enfield, Michael F. Sarosdy, M'liss A. Hudson, Mark S. Soloway, Ralph W deVere White, Joel Sheinfeld, Mark V. Jarowenko, Paul F. Schellhammer, Ed W. Schervish, Jay V. Patel, Gerald W. Chodak, Donald L. Lamm, Robert D. Johnson, Mary Henderson, George Adams

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Abstract

Objectives. To assess the clinical performance of the BTA TRAK assay and to compare it with that of voided urine cytology (VUC) and the Bard BTA test (BTA) in the detection of recurrent bladder cancer (BC). Methods. The study was performed on randomly selected archival voided urine samples for many of which VUC and/or BTA information was available. Sensitivity was determined in samples from patients with histologically confirmed recurrent BC. Specificity was determined in samples from healthy volunteers, patients with three categories of current medical conditions, and patients with a history of BC but no current evidence of disease. Results. The TRAK assay was positive in 156 of 216 samples for patients diagnosed with BC, for an overall sensitivity of 72%. Mean values increased with progressing grade and stage of disease. In the comparison between TRAK and VUC, the overall sensitivities were 68% and 25%, respectively (P <0.001). For Stages Ta and T1 and for all tumor grades, the sensitivity of the TRAK assay was significantly greater than that of VUC (P <0.001). TRAK sensitivity was also significantly better than that of BTA (73% versus 58%, P = 0.005). The specificity of the TRAK assay ranged from 75% in samples from patients with genitourinary disease to 97% in healthy volunteers. Conclusions. The TRAK assay is superior to VUC and the original BTA test in the detection of BC. The results of the study indicate that the TRAK assay may be a useful adjunct to cystoscopy in the management of patients with recurrent BC.

Original languageEnglish (US)
Pages (from-to)882-887
Number of pages6
JournalUrology
Volume50
Issue number6
DOIs
StatePublished - Dec 1997
Externally publishedYes

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Urinary Bladder Neoplasms
Cell Biology
Urine
Healthy Volunteers
Cystoscopy
Neoplasms

ASJC Scopus subject areas

  • Urology

Cite this

Ellis, W. J., Blumenstein, B. A., Ishak, L. M., Enfield, D. L., Sarosdy, M. F., Hudson, M. A., ... Adams, G. (1997). Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors. Urology, 50(6), 882-887. https://doi.org/10.1016/S0090-4295(97)00508-6

Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors. / Ellis, William J.; Blumenstein, Brent A.; Ishak, Laura M.; Enfield, David L.; Sarosdy, Michael F.; Hudson, M'liss A.; Soloway, Mark S.; deVere White, Ralph W; Sheinfeld, Joel; Jarowenko, Mark V.; Schellhammer, Paul F.; Schervish, Ed W.; Patel, Jay V.; Chodak, Gerald W.; Lamm, Donald L.; Johnson, Robert D.; Henderson, Mary; Adams, George.

In: Urology, Vol. 50, No. 6, 12.1997, p. 882-887.

Research output: Contribution to journalArticle

Ellis, WJ, Blumenstein, BA, Ishak, LM, Enfield, DL, Sarosdy, MF, Hudson, MA, Soloway, MS, deVere White, RW, Sheinfeld, J, Jarowenko, MV, Schellhammer, PF, Schervish, EW, Patel, JV, Chodak, GW, Lamm, DL, Johnson, RD, Henderson, M & Adams, G 1997, 'Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors', Urology, vol. 50, no. 6, pp. 882-887. https://doi.org/10.1016/S0090-4295(97)00508-6
Ellis, William J. ; Blumenstein, Brent A. ; Ishak, Laura M. ; Enfield, David L. ; Sarosdy, Michael F. ; Hudson, M'liss A. ; Soloway, Mark S. ; deVere White, Ralph W ; Sheinfeld, Joel ; Jarowenko, Mark V. ; Schellhammer, Paul F. ; Schervish, Ed W. ; Patel, Jay V. ; Chodak, Gerald W. ; Lamm, Donald L. ; Johnson, Robert D. ; Henderson, Mary ; Adams, George. / Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors. In: Urology. 1997 ; Vol. 50, No. 6. pp. 882-887.
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title = "Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors",
abstract = "Objectives. To assess the clinical performance of the BTA TRAK assay and to compare it with that of voided urine cytology (VUC) and the Bard BTA test (BTA) in the detection of recurrent bladder cancer (BC). Methods. The study was performed on randomly selected archival voided urine samples for many of which VUC and/or BTA information was available. Sensitivity was determined in samples from patients with histologically confirmed recurrent BC. Specificity was determined in samples from healthy volunteers, patients with three categories of current medical conditions, and patients with a history of BC but no current evidence of disease. Results. The TRAK assay was positive in 156 of 216 samples for patients diagnosed with BC, for an overall sensitivity of 72{\%}. Mean values increased with progressing grade and stage of disease. In the comparison between TRAK and VUC, the overall sensitivities were 68{\%} and 25{\%}, respectively (P <0.001). For Stages Ta and T1 and for all tumor grades, the sensitivity of the TRAK assay was significantly greater than that of VUC (P <0.001). TRAK sensitivity was also significantly better than that of BTA (73{\%} versus 58{\%}, P = 0.005). The specificity of the TRAK assay ranged from 75{\%} in samples from patients with genitourinary disease to 97{\%} in healthy volunteers. Conclusions. The TRAK assay is superior to VUC and the original BTA test in the detection of BC. The results of the study indicate that the TRAK assay may be a useful adjunct to cystoscopy in the management of patients with recurrent BC.",
author = "Ellis, {William J.} and Blumenstein, {Brent A.} and Ishak, {Laura M.} and Enfield, {David L.} and Sarosdy, {Michael F.} and Hudson, {M'liss A.} and Soloway, {Mark S.} and {deVere White}, {Ralph W} and Joel Sheinfeld and Jarowenko, {Mark V.} and Schellhammer, {Paul F.} and Schervish, {Ed W.} and Patel, {Jay V.} and Chodak, {Gerald W.} and Lamm, {Donald L.} and Johnson, {Robert D.} and Mary Henderson and George Adams",
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T1 - Clinical evaluation of the BTA trak assay and comparison to voided urine cytology and the Bard BTA test in patients with recurrent bladder tumors

AU - Ellis, William J.

AU - Blumenstein, Brent A.

AU - Ishak, Laura M.

AU - Enfield, David L.

AU - Sarosdy, Michael F.

AU - Hudson, M'liss A.

AU - Soloway, Mark S.

AU - deVere White, Ralph W

AU - Sheinfeld, Joel

AU - Jarowenko, Mark V.

AU - Schellhammer, Paul F.

AU - Schervish, Ed W.

AU - Patel, Jay V.

AU - Chodak, Gerald W.

AU - Lamm, Donald L.

AU - Johnson, Robert D.

AU - Henderson, Mary

AU - Adams, George

PY - 1997/12

Y1 - 1997/12

N2 - Objectives. To assess the clinical performance of the BTA TRAK assay and to compare it with that of voided urine cytology (VUC) and the Bard BTA test (BTA) in the detection of recurrent bladder cancer (BC). Methods. The study was performed on randomly selected archival voided urine samples for many of which VUC and/or BTA information was available. Sensitivity was determined in samples from patients with histologically confirmed recurrent BC. Specificity was determined in samples from healthy volunteers, patients with three categories of current medical conditions, and patients with a history of BC but no current evidence of disease. Results. The TRAK assay was positive in 156 of 216 samples for patients diagnosed with BC, for an overall sensitivity of 72%. Mean values increased with progressing grade and stage of disease. In the comparison between TRAK and VUC, the overall sensitivities were 68% and 25%, respectively (P <0.001). For Stages Ta and T1 and for all tumor grades, the sensitivity of the TRAK assay was significantly greater than that of VUC (P <0.001). TRAK sensitivity was also significantly better than that of BTA (73% versus 58%, P = 0.005). The specificity of the TRAK assay ranged from 75% in samples from patients with genitourinary disease to 97% in healthy volunteers. Conclusions. The TRAK assay is superior to VUC and the original BTA test in the detection of BC. The results of the study indicate that the TRAK assay may be a useful adjunct to cystoscopy in the management of patients with recurrent BC.

AB - Objectives. To assess the clinical performance of the BTA TRAK assay and to compare it with that of voided urine cytology (VUC) and the Bard BTA test (BTA) in the detection of recurrent bladder cancer (BC). Methods. The study was performed on randomly selected archival voided urine samples for many of which VUC and/or BTA information was available. Sensitivity was determined in samples from patients with histologically confirmed recurrent BC. Specificity was determined in samples from healthy volunteers, patients with three categories of current medical conditions, and patients with a history of BC but no current evidence of disease. Results. The TRAK assay was positive in 156 of 216 samples for patients diagnosed with BC, for an overall sensitivity of 72%. Mean values increased with progressing grade and stage of disease. In the comparison between TRAK and VUC, the overall sensitivities were 68% and 25%, respectively (P <0.001). For Stages Ta and T1 and for all tumor grades, the sensitivity of the TRAK assay was significantly greater than that of VUC (P <0.001). TRAK sensitivity was also significantly better than that of BTA (73% versus 58%, P = 0.005). The specificity of the TRAK assay ranged from 75% in samples from patients with genitourinary disease to 97% in healthy volunteers. Conclusions. The TRAK assay is superior to VUC and the original BTA test in the detection of BC. The results of the study indicate that the TRAK assay may be a useful adjunct to cystoscopy in the management of patients with recurrent BC.

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