Study of ROMA Blood Test Compared to CA125 for Earlier Ovarian Cancer Diagnosis in Women Visiting Their GP

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.

Transforming Ovarian Cancer Diagnostic Pathways