Performance of HE4 in ovarian cancer screening
Research type
Research Study
Full title
The performance of HE4/HE4 and CA72.4 combined with CA125/ROC algorithm in screening for ovarian cancer
IRAS ID
165752
Contact name
Usha Menon
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
14 years, 11 months, 31 days
Research summary
Ovarian cancer (OC) accounts for most of gynaecological cancer mortality. Women are usually diagnosed at advanced stage when long-term survival is poor. Majority (85%) occur in women over the age of 50. Only a few tumour markers have been validated for clinical use with the best known being CA125.
Performance of ultrasound or CA125-based strategy as screening tools for OC have been investigated in the past. Preliminary evidence from a randomised controlled trial (RCT) indicated improved survival in the screened group. A single-arm ultrasound study showed increased 5-year survival in study women compared to those from the same institution. The Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening RCT showed no impact of screening (using CA125>35kU/L and TVS) on mortality. The impact of screening with either ultrasound or CA125 interpreted using the Risk of Ovarian Cancer (ROC) algorithm from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) will be available in 2015. Preliminary evidence suggests that the multimodal approach has encouraging sensitivity, specificity and PPV.
Despite decades of research, CA125 remains the best performing marker in the context of screening. However, using preclinical samples from PLCO, Human Epididymis 4 (HE4) was shown as the next most promising marker (sensitivity 73% versus 86% for CA125). Utility of CA72.4 in differential diagnosis has already been assessed however its role in screening is not clear.
The aim of the current study is to determine the: (1) Performance of HE4 and/or CA72.4 combined with the ROC algorithm as a first line screening test; (2) Role of HE4 as a second line test (Reflex testing) to CA125 interpreted using ROC algorithm as primary screen - Performance of HE4 as an additional test at the annual screen where the ROC level is raised (>0.02%).
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0025
Date of REC Opinion
20 Jan 2015
REC opinion
Favourable Opinion