NCT06129968 Transforming Ovarian Cancer Diagnostic Pathways
| NCT ID | NCT06129968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Professor Sudha Sundar |
| Condition | Ovarian Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 34,000 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 34,000 participants in total. It began in 2024-01-23 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Sudha Sundar
PRINCIPAL INVESTIGATOR
University of Birmingham/Sandwell and West Birmingham NHS Trust
Frequently Asked Questions
Who can join the NCT06129968 clinical trial?
This trial is open to female participants only, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06129968 currently recruiting?
Yes, NCT06129968 is actively recruiting participants. Contact the research team at s.s.sundar@bham.ac.uk for enrollment information.
Where is the NCT06129968 trial being conducted?
This trial is being conducted at Birmingham, United Kingdom, Gateshead, United Kingdom, Wolverhampton, United Kingdom.
Who is sponsoring the NCT06129968 clinical trial?
NCT06129968 is sponsored by Professor Sudha Sundar. The principal investigator is Sudha Sundar at University of Birmingham/Sandwell and West Birmingham NHS Trust. The trial plans to enroll 34,000 participants.
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