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Phase II biomarker trial of a multimarker diagnostic for ovarian cancer.

Edgell T, Martin-Roussety G, Barker G, Autelitano DJ, Allen D, Grant P, Rice GE - J. Cancer Res. Clin. Oncol. (2010)

Bottom Line: The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01).At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

View Article: PubMed Central - PubMed

Affiliation: HealthLinx Limited, 576 Swan Street, Richmond, VIC 3121, Australia. t.edgell@healthlinx.com.au

ABSTRACT

Purpose: The primary hypothesis to be tested in this study was that the diagnostic performance (as assessed by the area under the receiver operator characteristic curve, AUC) of a multianalyte panel to correctly identify women with ovarian cancer was significantly greater than that for CA-125 alone.

Methods: A retrospective, case-control study (phase II biomarker trial) was conducted that involved 362 plasma samples obtained from women with ovarian cancer (n = 150) and healthy controls (n = 212). A multivariate classification model was developed that incorporated five biomarkers of ovarian cancer, CA-125; C-reactive protein (CRP); serum amyloid A (SAA); interleukin 6 (IL-6); and interleukin 8 (IL-8) from a modelling cohort (n = 179). The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.

Results: The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01). At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

Conclusions: The use of a panel of plasma biomarkers for the identification of women with ovarian cancer delivers a significant increase in diagnostic performance when compared to the performance of CA-125 alone.

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Related in: MedlinePlus

Variation in biomarker plasma concentrations presented as scatter plots and median values for controls (n = 212), all cases of ovarian cancer (n = 150) and early stage ovarian cancer (Stages I and II, n = 91). CA-125 U/ml; CRP μg/ml; SAA ng/ml; IL-6 and IL-8 pg/ml
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Fig1: Variation in biomarker plasma concentrations presented as scatter plots and median values for controls (n = 212), all cases of ovarian cancer (n = 150) and early stage ovarian cancer (Stages I and II, n = 91). CA-125 U/ml; CRP μg/ml; SAA ng/ml; IL-6 and IL-8 pg/ml

Mentions: The variation in biomarker plasma concentrations for controls, all cases of ovarian cancer and early stage (i.e. Stages I and II) ovarian cancer are presented in Fig. 1. The median concentration of all biomarkers was significantly greater in both case cohorts (i.e. validation and early stage) than in the control cohort (p < 0.001, as assessed by Mann–Whitney tests) (Table 4). No significant differences in biomarker plasma concentrations were identified between the modelling (n = 179) and validation (n = 183) cohorts (p > 0.05). No statistically significant effects of duration of sample storage at −80°C could be identified for any analyte (data not shown).Fig. 1


Phase II biomarker trial of a multimarker diagnostic for ovarian cancer.

Edgell T, Martin-Roussety G, Barker G, Autelitano DJ, Allen D, Grant P, Rice GE - J. Cancer Res. Clin. Oncol. (2010)

Variation in biomarker plasma concentrations presented as scatter plots and median values for controls (n = 212), all cases of ovarian cancer (n = 150) and early stage ovarian cancer (Stages I and II, n = 91). CA-125 U/ml; CRP μg/ml; SAA ng/ml; IL-6 and IL-8 pg/ml
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2874491&req=5

Fig1: Variation in biomarker plasma concentrations presented as scatter plots and median values for controls (n = 212), all cases of ovarian cancer (n = 150) and early stage ovarian cancer (Stages I and II, n = 91). CA-125 U/ml; CRP μg/ml; SAA ng/ml; IL-6 and IL-8 pg/ml
Mentions: The variation in biomarker plasma concentrations for controls, all cases of ovarian cancer and early stage (i.e. Stages I and II) ovarian cancer are presented in Fig. 1. The median concentration of all biomarkers was significantly greater in both case cohorts (i.e. validation and early stage) than in the control cohort (p < 0.001, as assessed by Mann–Whitney tests) (Table 4). No significant differences in biomarker plasma concentrations were identified between the modelling (n = 179) and validation (n = 183) cohorts (p > 0.05). No statistically significant effects of duration of sample storage at −80°C could be identified for any analyte (data not shown).Fig. 1

Bottom Line: The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01).At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

View Article: PubMed Central - PubMed

Affiliation: HealthLinx Limited, 576 Swan Street, Richmond, VIC 3121, Australia. t.edgell@healthlinx.com.au

ABSTRACT

Purpose: The primary hypothesis to be tested in this study was that the diagnostic performance (as assessed by the area under the receiver operator characteristic curve, AUC) of a multianalyte panel to correctly identify women with ovarian cancer was significantly greater than that for CA-125 alone.

Methods: A retrospective, case-control study (phase II biomarker trial) was conducted that involved 362 plasma samples obtained from women with ovarian cancer (n = 150) and healthy controls (n = 212). A multivariate classification model was developed that incorporated five biomarkers of ovarian cancer, CA-125; C-reactive protein (CRP); serum amyloid A (SAA); interleukin 6 (IL-6); and interleukin 8 (IL-8) from a modelling cohort (n = 179). The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.

Results: The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01). At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

Conclusions: The use of a panel of plasma biomarkers for the identification of women with ovarian cancer delivers a significant increase in diagnostic performance when compared to the performance of CA-125 alone.

Show MeSH
Related in: MedlinePlus