• Je něco špatně v tomto záznamu ?

Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification

Y. Lotan, JD. Raman, B. Konety, S. Daneshmand, F. Schroeck, SF. Shariat, P. Black, M. de Lange, S. Asroff, E. Goldfischer, M. Efros, KT. Chong, E. Huang, HL. Chua, QH. Wu, S. Yeow, W. Lau, J. Yong, M. Eng

. 2023 ; 209 (4) : 762-772. [pub] 20221230

Jazyk angličtina Země Spojené státy americké

Typ dokumentu multicentrická studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc23003701

PURPOSE: Cxbladder tests are urinary biomarker tests for detection of urothelial carcinoma. We developed enhanced Cxbladder tests that incorporate DNA analysis of 6 single nucleotide polymorphisms for the FGFR3 and TERT genes, in addition to the current 5 mRNA biomarkers and clinical risk factors. MATERIALS AND METHODS: Two multicenter, prospective studies were undertaken in: (1) U.S. patients with gross hematuria aged ≥18 years and (2) Singaporean patients with gross hematuria or microhematuria aged >21 years. All patients provided a midstream urine sample and underwent cystoscopy. Samples were retrospectively analyzed using enhanced Cxbladder-Triage (risk stratifies patients), enhanced Cxbladder-Detect (risk stratifies patients and detects positive patients), and the combination enhanced Cxbladder-Triage × Cxbladder-Detect. RESULTS: In the pooled cohort (N=804; gross hematuria: n=484, microhematuria: n=320), enhanced Cxbladder-Detect had a sensitivity of 97% (95% CI 89%-100%), specificity of 90% (95% CI 88%-92%), and negative predictive value of 99.7% (95% CI 99%-100%) for detection of urothelial carcinoma. Overall, 83% of patients were enhanced Cxbladder-Detect-negative (ie, needed no further work-up). Of 133 enhanced Cxbladder-Detect-positive patients, 59 had a confirmed tumor, of which 19 were low-grade noninvasive papillary carcinoma or papillary urothelial neoplasm of low malignant potential. In total, 40 tumors were high-grade Ta, T1-T4, Tis, including concomitant carcinoma in situ. Of the 74 patients with normal cystoscopy, 41 were positive by single nucleotide polymorphism analysis. Enhanced Cxbladder-Triage and enhanced Cxbladder-Detect had significantly better specificity than the first-generation Cxbladder tests (P < .001). CONCLUSIONS: This study in ethnically diverse patients with hematuria showed the analytical validity of the enhanced Cxbladder tests.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23003701
003      
CZ-PrNML
005      
20230425140818.0
007      
ta
008      
230418s2023 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1097/JU.0000000000003126 $2 doi
035    __
$a (PubMed)36583640
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Lotan, Yair $u University of Texas Southwestern, Dallas, Texas
245    10
$a Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification / $c Y. Lotan, JD. Raman, B. Konety, S. Daneshmand, F. Schroeck, SF. Shariat, P. Black, M. de Lange, S. Asroff, E. Goldfischer, M. Efros, KT. Chong, E. Huang, HL. Chua, QH. Wu, S. Yeow, W. Lau, J. Yong, M. Eng
520    9_
$a PURPOSE: Cxbladder tests are urinary biomarker tests for detection of urothelial carcinoma. We developed enhanced Cxbladder tests that incorporate DNA analysis of 6 single nucleotide polymorphisms for the FGFR3 and TERT genes, in addition to the current 5 mRNA biomarkers and clinical risk factors. MATERIALS AND METHODS: Two multicenter, prospective studies were undertaken in: (1) U.S. patients with gross hematuria aged ≥18 years and (2) Singaporean patients with gross hematuria or microhematuria aged >21 years. All patients provided a midstream urine sample and underwent cystoscopy. Samples were retrospectively analyzed using enhanced Cxbladder-Triage (risk stratifies patients), enhanced Cxbladder-Detect (risk stratifies patients and detects positive patients), and the combination enhanced Cxbladder-Triage × Cxbladder-Detect. RESULTS: In the pooled cohort (N=804; gross hematuria: n=484, microhematuria: n=320), enhanced Cxbladder-Detect had a sensitivity of 97% (95% CI 89%-100%), specificity of 90% (95% CI 88%-92%), and negative predictive value of 99.7% (95% CI 99%-100%) for detection of urothelial carcinoma. Overall, 83% of patients were enhanced Cxbladder-Detect-negative (ie, needed no further work-up). Of 133 enhanced Cxbladder-Detect-positive patients, 59 had a confirmed tumor, of which 19 were low-grade noninvasive papillary carcinoma or papillary urothelial neoplasm of low malignant potential. In total, 40 tumors were high-grade Ta, T1-T4, Tis, including concomitant carcinoma in situ. Of the 74 patients with normal cystoscopy, 41 were positive by single nucleotide polymorphism analysis. Enhanced Cxbladder-Triage and enhanced Cxbladder-Detect had significantly better specificity than the first-generation Cxbladder tests (P < .001). CONCLUSIONS: This study in ethnically diverse patients with hematuria showed the analytical validity of the enhanced Cxbladder tests.
650    _2
$a lidé $7 D006801
650    _2
$a mladiství $7 D000293
650    _2
$a dospělí $7 D000328
650    12
$a karcinom z přechodných buněk $x diagnóza $x genetika $x moč $7 D002295
650    12
$a nádory močového měchýře $x diagnóza $x genetika $x moč $7 D001749
650    _2
$a hematurie $x etiologie $x genetika $7 D006417
650    _2
$a prospektivní studie $7 D011446
650    _2
$a retrospektivní studie $7 D012189
650    _2
$a nádorové biomarkery $x genetika $x moč $7 D014408
650    _2
$a cystoskopie $7 D003558
650    12
$a karcinom in situ $7 D002278
650    _2
$a hodnocení rizik $7 D018570
650    _2
$a mutace $7 D009154
650    _2
$a senzitivita a specificita $7 D012680
650    _2
$a receptor fibroblastových růstových faktorů, typ 3 $x genetika $7 D051498
650    12
$a telomerasa $x genetika $7 D019098
655    _2
$a multicentrická studie $7 D016448
655    _2
$a časopisecké články $7 D016428
700    1_
$a Raman, Jay D $u Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania
700    1_
$a Konety, Badrinath $u Allina Health Cancer Institute, Minneapolis, Minnesota
700    1_
$a Daneshmand, Siamak $u Department of Urology, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California
700    1_
$a Schroeck, Florian $u White River Junction Veteran Affairs Medical Center, White River Junction, Vermont
700    1_
$a Shariat, Shahrokh F $u Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria $u Department of Urology, Weill Cornell Medical College, New York, New York $u Department of Urology, University of Texas Southwestern, Dallas, Texas $u Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic $u Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan
700    1_
$a Black, Peter $u Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada
700    1_
$a de Lange, Michel $u Pacific Edge Ltd, Dunedin, New Zealand
700    1_
$a Asroff, Scott $u New Jersey Urology, Mount Laurel Township, New Jersey
700    1_
$a Goldfischer, Evan $u Premier Medical Group, Poughkeepsie, New York
700    1_
$a Efros, Mitchell $u Accumed Research Associates, Garden City, New York
700    1_
$a Chong, Kian Tai $u Surgi-TEN Specialists, Farrer Park Hospital, Singapore $u PanAsia Surgery, Mount Elizabeth Novena Specialist Centre, Singapore
700    1_
$a Huang, Eugene $u Department of Urogynaecology, KK Women's and Children's Hospital, Singapore
700    1_
$a Chua, Hong Liang $u Department of Urogynaecology, KK Women's and Children's Hospital, Singapore
700    1_
$a Wu, Qing Hui $u Department of Urology, National University Hospital, Singapore
700    1_
$a Yeow, Siying $u Department of Urology, Khoo Teck Puat Hospital, Singapore
700    1_
$a Lau, Weida $u Department of Urology, Khoo Teck Puat Hospital, Singapore
700    1_
$a Yong, Jin $u Department of Urology, Singapore General Hospital, Singapore
700    1_
$a Eng, Molly $u Department of Urology, Khoo Teck Puat Hospital, Singapore
773    0_
$w MED00003040 $t The Journal of urology $x 1527-3792 $g Roč. 209, č. 4 (2023), s. 762-772
856    41
$u https://pubmed.ncbi.nlm.nih.gov/36583640 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20230418 $b ABA008
991    __
$a 20230425140814 $b ABA008
999    __
$a ok $b bmc $g 1924397 $s 1189910
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 209 $c 4 $d 762-772 $e 20221230 $i 1527-3792 $m The Journal of urology $n J Urol $x MED00003040
LZP    __
$a Pubmed-20230418

Najít záznam

Citační ukazatele

Možnosti archivace