RecruitingNCT06129968

Transforming Ovarian Cancer Diagnostic Pathways

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

Sponsor

Professor Sudha Sundar

Enrollment

34,000 participants

Start Date

Jan 23, 2024

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer

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

Sex: FEMALE

Inclusion Criteria1

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 Criteria2

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.