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Trial Title:
Transforming Ovarian Cancer Diagnostic Pathways
NCT ID:
NCT06129968
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
ovarian cancer
diagnosis
Primary care
CA125
HE4
ROMA algorithm
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The goal of this observational cohort study is to compare the diagnostic accuracy and
cost effectiveness of Risk of Malignancy Algorithm (ROMA) compared with CA125 in the
diagnosis of ovarian cancer in patients attending their general practitioner (GP) with
symptoms that sometimes might indicate ovarian cancer. The main questions it aims to
answer are: • what is the accuracy of the ROMA algorithm which uses the blood tests CA125
and Human epididymis protein 4 (HE4) compared to CA125 in diagnosing ovarian cancer,
particularly early-stage ovarian cancer, in women tested for suspected ovarian cancer
from primary care? • What is the cost-effectiveness of ROMA versus CA125 testing in
primary care to diagnose ovarian cancer? When a participant's GP orders a CA125 blood
test, the blood will also be tested for HE4 and the ROMA algorithm calculated. The
diagnostic accuracy of ROMA and CA125 will be compared to see if ROMA would be a better
diagnostic test for ovarian cancer when used in the primary care setting.
Detailed description:
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 Human epididymis protein 4 (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. A 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, it is necessary 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 National Health Service (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. This study is one component of the SONATA project. In it, 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 the investigators to establish cost effectiveness of
ROMA and definitive data on accuracy in primary care.
Criteria for eligibility:
Study pop:
- Women presenting to primary care with suspected ovarian cancer who are tested for
the biomarker CA125 according to current standards of care for investigation of
CA125 in the primary care setting.
- All samples requested by GPs for testing with CA125 in women in two large labs,
Black Country Pathology Wervices and South Tyne and Wear labs, will be included.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Women presenting to primary care with suspected ovarian cancer who are tested for
the biomarker CA125 according to current standards of care for investigation of
CA125 in the primary care setting.
Exclusion Criteria:
- Patients presenting to primary care who do not have potential symptoms of ovarian
cancer.
- Women with symptoms sometimes associated with ovarian cancer not tested for ovarian
cancer.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sandwell and West Birmingham NHS TRUST
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Sudha Sundar
Facility:
Name:
Gateshead Health NHS Foundation Trust
Address:
City:
Gateshead
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Nithya Ratnavelu
Facility:
Name:
The Royal Wolverhampton NHS Trust
Address:
City:
Wolverhampton
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Olumide Ofinran
Start date:
January 23, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Professor Sudha Sundar
Agency class:
Other
Collaborator:
Agency:
University of Birmingham
Agency class:
Other
Source:
Sandwell & West Birmingham Hospitals NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129968
