Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer
2009

Development of a Blood Test for Ovarian Cancer

Sample size: 363 publication 10 minutes Evidence: moderate

Author Information

Author(s): Amonkar Suraj D., Bertenshaw Greg P., Chen Tzong-Hao, Bergstrom Katharine J., Zhao Jinghua, Seshaiah Partha, Yip Ping, Mansfield Brian C.

Primary Institution: Correlogic Systems, Inc.

Hypothesis

Can a serum-based multivariate assay effectively distinguish women with ovarian cancer from those with benign conditions?

Conclusion

The study developed a blood-based assay using 11 analytes that can distinguish women with ovarian cancer from those with benign conditions, showing promising sensitivity and specificity.

Supporting Evidence

  • The classifier achieved 91.3% sensitivity and 88.5% specificity in distinguishing ovarian cancer from benign conditions.
  • Using a training set of 91 stage I data sets, an 11-analyte profile was identified as informative for all stages of ovarian cancer.
  • Preliminary evaluation suggests the test has the potential to offer approximately 90% sensitivity and specificity.

Takeaway

Researchers created a blood test that can help tell if a woman has ovarian cancer or just a harmless condition, which is really important for early diagnosis.

Methodology

The study used high-throughput multiplexed immunoassays to analyze serum samples from women with ovarian cancer and benign conditions.

Potential Biases

Potential bias due to the testing samples being analyzed at the same time as those used in model building.

Limitations

The performance of the classifier is preliminary and may be over-optimistic due to the testing samples being sourced from the same collection as the training set.

Participant Demographics

The study included 176 women with ovarian cancer and 187 controls, with a median age of 56 years.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI, 91.0–99.2%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0004599

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