Healthcare Professionals

Clinical Studies

Numerous clinical studies have demonstrated the ability of HE4 to increase the specificity and sensitivity of CA125 in the detection of ovarian cancer—and the benefit of using CA125 in combination with HE4 to stratify patients by risk and ensure their triage to appropriate centers of care.

Here, you can review a selection of these clinical studies and learn more about the:

  • various biomarkers that were investigated
  • discovery of the CA125 + HE4 combination
  • optimal management of ovarian cancer

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PDF FileHuhtinen K, et al. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.
British J  Cancer. 2009;100(8):1315-1319.

This study investigated the concentration of HE4 and CA125 in the serum of patients diagnosed with endometriosis, ovarian cysts, endometrial cancer, and ovarian cancer as well as healthy controls.

Results
The combination of HE4 + CA125 was shown to accurately differentiate healthy patients and patients with endometriosis from those diagnosed with ovarian cancer.

PDF FileLi J, et. al.  HE4 as a biomarker for ovarian and endometrial cancer management.
Expert Rev Mol Diagn. 2009;9(6):555–566.

In this review, HE4 is discussed as a biomarker for the diagnoses, detection, and monitoring of ovarian and endometrial cancer.

Results
Preliminary data show that HE4 may have more potential than CA125 in discriminating benign from cancerous ovarian masses, and has the strongest correlation with endometrial cancer of all markers tested to date. Utilizing risk stratification, a panel of biomarkers including HE4 may ultimately be useful for detecting ovarian and endometrial cancer at an early stage in patients at high risk.

Moore RG, et al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in
patients with a pelvic mass.

Gynecol Oncol. 2008;108(2):402-408.

Moore and colleagues investigated a series of 9 novel biomarkers, alone and in combination, in patients with ovarian cancer.

Results
The combination of HE4 and CA125 resulted in the highest sensitivity over any other single marker or dual combination.

Video: Richard G. Moore, M.D., FACOG, FACS

Richard G. Moore, M.D., FACOG, FACS - 6:34
Richard G. Moore, M.D., FACOG, FACS discusses the The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass, Gynecol. Oncology, 2008.

Moore RG, et. al. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of
ovarian cancer in patients with a pelvic mass.

Gynecol Oncol. 2009;112(1):40-46.

This publication reports on a prospective, multi-center trial to validate a predictive model based on the combination of CA125 + HE4 to assess the risk of epithelial ovarian cancer (EOC) in women with a pelvic mass.

Results
This study demonstrates the benefit of CA125 in combination with HE4 in the risk of malignancy algorithm to identify women with a pelvic mass, who are better treated by an ovarian cancer specialist in a surgical center.

Video: Richard G. Moore, M.D., FACOG, FACS

Richard G. Moore, M.D., FACOG, FACS - 4:31
Richard G. Moore, M.D., FACOG, FACS reviews A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction o ovarian cancer in patients with a pelvic mass, Gynecol. Oncology, 2009.

Moore RG, et al. Utility of a novel serum tumor biomarker HE4 in patients with endometrioid adenocarcinoma of the uterus.
Gynecol. Oncol. 2008;110(2):196-201.

Researchers investigated 4 biomarkers (CA125, HE4, CA72-4, SMRP), alone and in combination, in patients with endometrioid tumors to evaluate the ability of biomarkers to identify women with cancer.

Results
A combination of CA125 and HE4 raised the sensitivity compared to CA125 alone and HE4 in patients with Stage II-IV disease. HE4 alone or in combination with CA125 appears to be an excellent marker and may be an effective tool for the early detection of recurrence or for monitoring the response to therapy.

You can review a summary of all of our publications in the HE4 Publication Brochure PDF File.