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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Sandwell and West Birmingham NHS TRUST
NOT_YET_RECRUITING
Birmingham
Gateshead Health NHS Foundation Trust
RECRUITING
Gateshead
The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Contact Information
Primary
Sudha Sundar
s.s.sundar@bham.ac.uk
+441214144477
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 34000
Related Therapeutic Areas
Sponsors
Leads: Professor Sudha Sundar
Collaborators: University of Birmingham

This content was sourced from clinicaltrials.gov