What is this study trying to find out about ovarian cancer?

This study aims to find out if the ROMA algorithm, which uses two blood tests, is more accurate and cost-effective than the current CA125 test in diagnosing ovarian cancer in women with symptoms seen in primary care. It focuses especially on detecting cancer earlier to improve diagnosis. The study is led by Professor Sudha Sundar and is part of a larger NHS programme.

Who may be eligible for this ovarian cancer clinical trial?

Women who have symptoms that might suggest ovarian cancer and whose GP has ordered a CA125 blood test may be eligible. The study is for females of any age attending primary care. Patients without symptoms or not tested for ovarian cancer are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this ovarian cancer clinical trial?

Study-related care, including blood tests and all trial assessments, is provided at no cost. However, personal travel expenses or other costs to attend appointments may vary and are not guaranteed to be reimbursed.

Actively Recruiting

FEMALE

ID06129968

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

Led by Professor Sudha Sundar · Updated on 2025-05-16

34000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the use of the Risk of Malignancy Algorithm ROMA, which combines two blood tests, CA125 and Human epididymis protein 4 HE4, to improve the diagnosis of ovarian cancer in women showing symptoms in primary care. This observational study aims to compare how accurately ROMA detects ovarian cancer, especially in early stages, against the current standard CA125 test, and to evaluate the cost-effectiveness of using ROMA in general practice settings. The study involves testing blood samples collected when a general practitioner orders a CA125 test for a woman suspected of having ovarian cancer. Along with CA125, the blood will also be tested for HE4, and the ROMA score will be calculated. By comparing the diagnostic accuracy of ROMA and CA125, researchers hope to determine whether ROMA could help identify more cases of ovarian cancer earlier and more cost-effectively. This research is part of a wider NHS programme called SONATA that aims to improve ovarian cancer diagnosis pathways. Participants will be women who present to primary care with symptoms that may indicate ovarian cancer and who are tested for CA125. The study will monitor sensitivity and specificity of ROMA versus CA125 in detecting ovarian cancer over 12 months, focusing on early-stage cases. Cost-effectiveness will also be assessed. The study uses existing blood samples and routine clinical data, without changing participants care, and aims to provide evidence for improving diagnostic testing in primary care.

CONDITIONS

Brief Title

Transforming Ovarian Cancer Diagnostic Pathways

Who Can Participate

FEMALE

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.

Research Team

Sudha Sundar

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