Comparing diagnostic methods for ovarian cancer
Official title: Transforming Ovarian Cancer Diagnostic Pathways (TranSforming Ovarian caNcer diAgnosTic pAthways: A Hybrid Type 1 Effectiveness-implementation Study of a Novel Biomarker Based, Threshold Driven Pathway for Earlier Ovarian Cancer Diagnosis
Run by Sandwell & West Birmingham Hospitals NHS Trust · NCT06129968 · Data updated 2026-11-12
This study is testing if a new blood test that includes a specific marker can better diagnose ovarian cancer in women with symptoms compared to the traditional CA125 test.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 34000 (estimated) |
| Sponsor | Sandwell & West Birmingham Hospitals NHS Trust Academic / other |
| Locations | 3 sites (Birmingham and 2 other locations) |
| Status | Recruiting |
| Started | January 23, 2024 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT06129968 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women presenting to primary care with symptoms that may indicate ovarian cancer and who are being tested for CA125.
✕Probably not a fit
Patients who do not exhibit potential symptoms of ovarian cancer or are not being tested for ovarian cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to evaluate the diagnostic accuracy and cost-effectiveness of the Risk of Malignancy Algorithm (ROMA) compared to the CA125 blood test in diagnosing ovarian cancer in women presenting with symptoms at their general practitioner. The study will analyze how well ROMA, which incorporates the HE4 biomarker, performs in detecting early-stage ovarian cancer compared to the traditional CA125 test. By testing blood samples for both CA125 and HE4, the study seeks to determine if ROMA can improve early diagnosis rates and reduce unnecessary referrals. The findings will help inform the potential integration of ROMA into standard primary care practices for ovarian cancer diagnosis.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of ovarian cancer, improving patient outcomes.
How similar studies have gone: Previous studies have shown that ROMA is superior in detecting early-stage ovarian cancer compared to CA125, but this study aims to confirm these findings in a primary care setting.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom Recruiting -
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom Recruiting -
Sandwell and West Birmingham NHS TRUST
Birmingham, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Sudha Sundar — University of Birmingham/Sandwell and West Birmingham NHS Trust
- Study coordinator: Sudha Sundar
- Email: s.s.sundar@bham.ac.uk
- Phone: +441214144477
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.