NCT06129968Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 34000 (estimated)
- First submitted
- 31 Oct 2023
- Start date
- 23 Jan 2024
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Professor Sudha Sundar
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT06129968
What you commit to
- Study type: Observational
- Planned participants: 34000
- From 23 Jan 2024 to the primary completion date, 31 Jul 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sandwell and West Birmingham NHS TRUST Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Gateshead Health NHS Foundation Trust Coordinator of this site? Confirm its status | Gateshead | United Kingdom | Recruiting |
| The Royal Wolverhampton NHS Trust Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.