Biomarkers for ovarian cancer risk assessment
Research type
Research Study
Full title
Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study
IRAS ID
218202
Contact name
Emma Crosbie
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
Summary of Research
Ovarian cancer is the 6th most common cancer affecting women worldwide with around 7000 women diagnosed each year in the UK alone. Most of the symptoms of ovarian cancer are vague, such as bloating and abdominal discomfort, making diagnosis challenging. Unfortunately, ovarian cancer is not diagnosed until late for most women, making it much more difficult to cure. Currently, less than half of patients with ovarian cancer survive for 5 years after diagnosis.When a patient attends their GP with symptoms that might suggest ovarian cancer, they undergo a blood test known as CA125. While CA125 picks up many patients with ovarian cancer, a number of harmless conditions can also produce a positive result. This means that many women go through unnecessary further tests, procedures and stress. In addition, CA125 does not pick up all ovarian cancers, with around half of patients with early disease having a normal result. Better tests are urgently needed to identify ovarian cancer at an early stage and, also, to better identify patients who do not have cancer.
A number of studies conducted in secondary care have shown that a blood marker, known as HE4, is more accurate than CA125 in the identification of ovarian cancer. In this study, we will compare the performance of HE4 and CA125 in symptomatic women presenting to their GP. CA125 samples from 1200 women will undergo additional testing for HE4 and patients with abnormal results will be followed up to determine outcomes. This pilot study will serve as a model for larger comprehensive studies and help us to determine which is the best test to identify ovarian cancer in primary care. As such, the results could have a positive impact on the care of women throughout the UK.
Summary of Results
Ovarian cancer is the most common cause of death from gynaecological cancer in the UK. Survival is better when the disease is diagnosed early. However, identifying ovarian cancer is challenging because symptoms are non-specific. Simple accurate tests are needed to help identify ovarian cancer in symptomatic women. HE4, a relatively new blood biomarker, has shown promise in the hospital setting. This study aimed to assess whether HE4 would improve ovarian cancer diagnosis in women with symptoms in primary care. We found combining HE4 levels with the currently used test (CA125) within an algorithm (Risk of Ovarian Malignancy Algorithm) improved detection of ovarian cancer in primary care, particularly in women under 50 years of age, where diagnosis is more challenging, however our results require validation in a larger sample. This study advances our knowledge of HE4 as an ovarian cancer biomarker in the primary care setting.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0667
Date of REC Opinion
21 Dec 2017
REC opinion
Favourable Opinion