HE4 and CA125 as a diagnostic test in ovarian cancer: prospective validation of the Risk of Ovarian Malignancy Algorithm
2011

HE4 and CA125 in Ovarian Cancer Diagnosis

Sample size: 389 publication Evidence: moderate

Author Information

Author(s): Van Gorp T, Cadron I, Despierre E, Daemen A, Leunen K, Amant F, Timmerman D, De Moor B, Vergote I

Primary Institution: Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven

Hypothesis

The study aims to validate the Risk of Ovarian Malignancy Algorithm (ROMA) using HE4 and CA125 for diagnosing ovarian cancer.

Conclusion

The study found that HE4 and ROMA did not improve the detection of malignant disease compared to CA125 alone.

Supporting Evidence

  • ROMA had a ROC-AUC of 0.898 for all malignant tumors.
  • HE4 had a ROC-AUC of 0.857, while CA125 had a ROC-AUC of 0.877.
  • For EOC vs benign disease, the ROC-AUC of ROMA increased to 0.913.

Takeaway

Doctors used two blood tests, HE4 and CA125, to see if they could help find ovarian cancer, but they didn't do any better than just using CA125 alone.

Methodology

The study enrolled women with pelvic masses scheduled for surgery and measured preoperative serum levels of HE4 and CA125 in 389 patients.

Limitations

The study did not exclude borderline tumors, NEOC, and metastatic tumors, which may affect the generalizability of the results.

Participant Demographics

The mean age of patients was 46.3 years for benign cases and 57.8 years for malignant cases, with a higher proportion of post-menopausal women in the malignant group.

Statistical Information

P-Value

<0.0001

Confidence Interval

95%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6606092

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