SONATA 1.0
Research type
Research Study
Full title
Transforming Ovarian Cancer diagnostic pathways (TranSforming Ovarian caNcer diAgnosTic pAthways - SONATA)
IRAS ID
326650
Contact name
Sudha S Sundar
Contact email
Sponsor organisation
Sandwell and West Birmingham NHS Trust
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
A woman’s chances of surviving 5 years after Ovarian Cancer (OC) diagnosis drops from 90% if diagnosed at Stage 1 to 15% at Stage 4. Currently, GPs use a blood test called CA125 and ultrasound scan to decide whether to refer a woman to hospital for suspected OC. CA125 misses 50% of early-stage cancers (Stage 1 and 2); both tests cause unnecessary referrals.
Recently, a blood test called HE4 in combination with CA125 in a formula called ROMA (Risk of Malignancy Algorithm) has been developed. ROMA is used by doctors in the US and Europe to guide referrals and recommended by the American College of Obstetrics and Gynaecology. Our large Cochrane systematic review of 30,000+ patients across 50 papers shows ROMA detects more cancers at earlier stage than a combination of CA125 and ultrasound. All included studies were conducted in hospital where OC rates are high, however a model at 3% OC rate shows that ROMA is superior. Before the test can be introduced in NHS, we need to confirm this evidence in a large primary care study and establish cost effectiveness.
The wider NHS cancer programme funded SONATA project evaluates an integrated pathway from community to cancer specialists using ROMA. It includes NHS pilots in primary and secondary care to establish how practice can be supported to change, evaluates facilitators and barriers to change as well as a community campaign to promote OC awareness.
We seek ethics permission for one component of the SONATA project. In this, two large NHS labs will additionally test 41,000 blood samples from women whose GPs requested CA125 testing for suspected OC with ROMA to accurately identify the number of patients who can be detected earlier. This will enable us to establish cost effectiveness of ROMA and definitive data on accuracy in primary care.REC name
West of Scotland REC 4
REC reference
23/WS/0107
Date of REC Opinion
14 Jul 2023
REC opinion
Favourable Opinion