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

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

Plain Language Summary

Simplified for easier understanding

This study is examining how women with possible symptoms of ovarian cancer navigate the diagnostic process in primary care — from the initial CA125 blood test to eventual diagnosis — with the aim of finding ways to speed up detection and reduce delays. **You may be eligible if:** - You are a woman presenting to a primary care doctor (GP) with symptoms that could suggest ovarian cancer - Your doctor has already ordered a CA125 blood test as part of standard care for investigating your symptoms **You may NOT be eligible if:** - You have no potential symptoms of ovarian cancer - You have symptoms sometimes associated with ovarian cancer but your doctor has not ordered a CA125 test for ovarian cancer investigation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(3)

Sandwell and West Birmingham NHS TRUST

Birmingham, United Kingdom

Gateshead Health NHS Foundation Trust

Gateshead, United Kingdom

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06129968


Related Trials