Actively Recruiting
Transforming Ovarian Cancer Diagnostic Pathways
Led by Professor Sudha Sundar · Updated on 2025-05-16
34000
Participants Needed
3
Research Sites
79 weeks
Total Duration
On this page
Sponsors
P
Professor Sudha Sundar
Lead Sponsor
U
University of Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transforming Ovarian Cancer Diagnostic Pathways
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Sandwell and West Birmingham NHS TRUST
Birmingham, United Kingdom
Not Yet Recruiting
2
Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom
Actively Recruiting
3
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Actively Recruiting
Research Team
S
Sudha Sundar
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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