HE4 in primary care .
Research type
Research Study
Full title
Evaluation of the distribution of serum HE4 values in primary care patients being assessed for possible ovarian cancer
IRAS ID
225328
Contact name
S. Michael Crawford
Contact email
Sponsor organisation
Airedale NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
n the UK, the method of diagnosing ovarian cancer recommended by NICE depends on the GP requesting a CA125 blood test and if this abnormal doing an ultrasound. However the majority of elevated CA125 values are false positives, the woman does not have ovarian cancer. Adding the HE4 test to CA125 may make the procedure more accurate so fewer expensive ultrasounds can be done for the same number of blood tests or that more women can be tested to find early cancer without doing many more ultrasounds. By measuring HE4 in women attending Airedale Hospital for the ultrasound we can evaluate the performance of the test.
We plan to seek consent from women when they attend for ultrasound to measure HE4 in a fresh blood test and to correlate the findings with the test outcome. We will ascertain whether low values of HE4 increase the specificity of the initial blood test without sacrificing sensitivity, that is to reduce the number of false positives whilst detecting the cancers. We will also explore its meaning in women diagnosed with ovarian, and related cancer who do not have elevated CA125 because HE4 may detect such cancers where CA125 has failed.REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0515
Date of REC Opinion
23 Mar 2017
REC opinion
Unfavourable Opinion