Ovarian CancerSONATANCT06129968
Transforming Ovarian Cancer Diagnostic Pathways
An observational study of Ovarian Cancer, run by Professor Sudha Sundar at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 34,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 23 Jan 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: * 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. * All samples requested by GPs for testing with CA125 in women in two large labs, Black Country Pathology Wervices and South Tyne and Wear labs, will be included.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Sandwell and West Birmingham NHS TRUST
Birmingham
Sudha Sundar
- Recruiting
Gateshead Health NHS Foundation Trust
Gateshead
Nithya Ratnavelu
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton
Olumide Ofinran
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, diagnosis, Primary care, CA125, HE4, ROMA algorithm
- Medical subject headings
- Ovarian Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of ROMA versus CA125 in early stage ovarian cancer
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Measured: 12 months
Specificity of ROMA versus CA125 in early stage ovarian cancer
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Measured: 12 months
Secondary outcomes (3)
Sensitivity of ROMA versus CA125 in all stages of ovarian cancer
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Measured: 12 months
Specificity of ROMA versus CA125 in all stages of ovarian cancer
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
Measured: 12 months
Incremental Cost Effectiveness Ratio (ICER) of ROMA versus CA125
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start23 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Sudha Sundar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor-investigator, Professor Sudha Sundar, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Sudha Sundar, Principal investigator, University of Birmingham/Sandwell and West Birmingham NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129968
- Sponsor's protocol ID
- 23/WS/0107
- Other IDs
- 23/CAG/0086
- Acronym
- SONATA
- Status last verified
- May 2025
- First submitted
- 31 Oct 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06129968
- Acronym / sponsor ID
- SONATA / 23/WS/0107
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, diagnosis, Primary care, CA125, HE4, ROMA algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34,000 participants (estimated)
- Lead sponsor
- Professor Sudha SundarUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * 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. * All samples requested by GPs for testing with CA125 in women in two large labs, Black Country Pathology Wervices and South Tyne and Wear labs, will be included.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of ROMA versus CA125 in early stage ovarian cancer
Time frame: 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
Time frame: 12 months
Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.
3 secondary outcomes
Sensitivity of ROMA versus CA125 in all stages of ovarian cancer
Time frame: 12 months
Specificity of ROMA versus CA125 in all stages of ovarian cancer
Time frame: 12 months
Incremental Cost Effectiveness Ratio (ICER) of ROMA versus CA125
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sudha Sundar principal investigator
University of Birmingham/Sandwell and West Birmingham NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Professor Sudha Sundar at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sudha Sundar (+441214144477, s.s.sundar@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ROMA versus CA125 in early stage ovarian cancer (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.