SONATA: Transforming Ovarian Cancer Diagnostic Pathways

Sponsor

Professor Sudha Sundar (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129968

Collaborator

University of Birmingham (Other)

34,000

Enrollment

Locations

Anticipated Duration (Months)

11333.3

Patients Per Site

540.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer

Detailed Description

A woman's chances of surviving 5 years after Ovarian Cancer (OC) diagnosis drops from 90% if diagnosed at Stage 1 to 15% at Stage 4. Currently, GPs use a blood test called CA125 and ultrasound scan to decide whether to refer a woman to hospital for suspected OC. CA125 misses 50% of early-stage cancers (Stage 1 and 2); both tests cause unnecessary referrals. Recently, a blood test called Human epididymis protein 4 (HE4) in combination with CA125 in a formula called ROMA (Risk of Malignancy Algorithm) has been developed. ROMA is used by doctors in the US and Europe to guide referrals and recommended by the American College of Obstetrics and Gynaecology. A large Cochrane systematic review of 30,000+ patients across 50 papers shows ROMA detects more cancers at earlier stage than a combination of CA125 and ultrasound. All included studies were conducted in hospital where OC rates are high, however a model at 3% OC rate shows that ROMA is superior. Before the test can be introduced in NHS, it is necessary to confirm this evidence in a large primary care study and establish cost effectiveness. The wider NHS cancer programme funded SONATA project evaluates an integrated pathway from community to cancer specialists using ROMA. It includes National Health Service (NHS) pilots in primary and secondary care to establish how practice can be supported to change, evaluates facilitators and barriers to change as well as a community campaign to promote OC awareness. This study is one component of the SONATA project. In it, two large NHS labs will additionally test 41,000 blood samples from women whose GPs requested CA125 testing for suspected OC with ROMA to accurately identify the number of patients who can be detected earlier. This will enable the investigators to establish cost effectiveness of ROMA and definitive data on accuracy in primary care.

Study Design

Study Type:

Observational

Anticipated Enrollment :

34000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Outcome Measures

Primary Outcome Measures

Sensitivity of ROMA versus CA125 in early stage ovarian cancer [12 months]
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Specificity of ROMA versus CA125 in early stage ovarian cancer [12 months]
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.

Secondary Outcome Measures

Sensitivity of ROMA versus CA125 in all stages of ovarian cancer [12 months]
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Specificity of ROMA versus CA125 in all stages of ovarian cancer [12 months]
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Incremental Cost Effectiveness Ratio (ICER) of ROMA versus CA125 [12 months]
Derived from a model-based cost consequence analysis from an NHS and Personal Social Services perspective comparing the new primary care diagnostic pathway using ROMA to the standard primary care pathway of CA125 followed by ultrasound.

Other Outcome Measures

Number of health care visits [12 months]
As identified from hospital gynaecological oncology centre multidisciplinary team databases.
Rate of Emergency Hospital admissions [12 months]
As identified from hospital gynaecological oncology centre multidisciplinary team databases.
Cancer stage [12 months]
FIGO stage identified from hospital gynaecological oncology centre multidisciplinary team databases.
% of each treatment modality (surgical resection and chemotherapy, chemotherapy alone, surgical resection alone, or other) [12 months]
As identified from hospital gynaecological oncology centre multidisciplinary team databases.
Survival [12 months]
Calculated from date of death or of last point of contact and from diagnosis date recorded in hospital gynaecological oncology centre multidisciplinary team databases.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Sandwell and West Birmingham NHS TRUST	Birmingham	United Kingdom
2	Gateshead Health NHS Foundation Trust	Gateshead	United Kingdom
3	The Royal Wolverhampton NHS Trust	Wolverhampton	United Kingdom