NCT06129968

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

October 31, 2023

Last Update Submit

May 13, 2025

Conditions

Ovarian Cancer

Keywords

ovarian cancerdiagnosisPrimary careCA125HE4ROMA algorithm

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of ROMA versus CA125 in early stage ovarian cancer

    Cancer diagnoses will be identified from hospital gynaecological oncology centre multidisciplinary team databases.

    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.

    12 months

Secondary Outcomes (3)

  • Sensitivity of ROMA versus CA125 in all stages of ovarian cancer

    12 months

  • Specificity of ROMA versus CA125 in all stages of ovarian cancer

    12 months

  • Incremental Cost Effectiveness Ratio (ICER) of ROMA versus CA125

    12 months

Other Outcomes (5)

  • Number of health care visits

    12 months

  • Rate of Emergency Hospital admissions

    12 months

  • Cancer stage

    12 months

  • +2 more other outcomes

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sandwell and West Birmingham NHS TRUST

Birmingham, United Kingdom

NOT YET RECRUITING

Gateshead Health NHS Foundation Trust

Gateshead, United Kingdom

RECRUITING

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, 41000 anticipated as some patients will have repeat tests.

MeSH Terms

Conditions

Ovarian NeoplasmsDisease

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sudha Sundar

    University of Birmingham/Sandwell and West Birmingham NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudha Sundar

CONTACT

+441214144477s.s.sundar@bham.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Gynaecological Cancer

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 13, 2023

Study Start

January 23, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)