Comparing diagnostic methods for ovarian cancer
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
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 |
|---|---|
| Enrollment | 34000 (estimated) |
| Sex | Female |
| Sponsor | Sandwell & West Birmingham Hospitals NHS Trust Academic / other |
| Locations | 3 sites (Birmingham and 2 other locations) |
| Trial ID | NCT06129968 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women presenting to primary care with symptoms that may indicate ovarian cancer and who are being tested for CA125.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham and 2 other locations
- Sandwell and West Birmingham NHS TRUST — Birmingham, United Kingdom (Not_yet_recruiting)
- Gateshead Health NHS Foundation Trust — Gateshead, United Kingdom (Recruiting)
- The Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.