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Transforming Ovarian Cancer Diagnostic Pathways

NCT06129968 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34000

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER

  • Professor Sudha Sundar

    lead OTHER

Principal Investigators

  • Sudha Sundar · University of Birmingham/Sandwell and West Birmingham NHS Trust

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129968 on ClinicalTrials.gov