Condition category
Cancer
Date applied
08/06/2018
Date assigned
13/06/2018
Last edited
12/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chloe Barr

ORCID ID

Contact details

5th Floor Research Office
Saint Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Type

Scientific

Additional contact

Dr Emma Crosbie

ORCID ID

Contact details

5th Floor Research Office
Saint Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 218202

Study information

Scientific title

Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study

Acronym

Study hypothesis

Primary objective: To determine the specificity of HE4 and CA125 in a symptomatic primary care population.
Secondary objectives: To estimate the sensitivities of HE4 and CA125 in a symptomatic primary care population.

The trialists hypothesize that HE4 will add to the diagnostic accuracy of CA125 in a symptomatic primary care population. They aim to determine the specificity and sensitivity of HE4 as a diagnostic biomarker for ovarian cancer. They will look at its independent performance and its performance in conjunction with CA125.

Ethics approval

HRA: South Central - Oxford B Research Ethics Committee, 21/12/2017, ref: 17/SC/0667

Study design

Single-centre observational case series pilot study

Primary study design

Observational

Secondary study design

Case series

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Ovarian cancer

Intervention

Study setting: Central Manchester University Hospitals NHS Foundation Trust (CMFT). This centre receives around 900 CA125 samples from primary care each year.

Study duration: Total: 20 months
Phase 1: 16 months
Phase 2: 20 months

Methods overview
The study consists of 2 overlapping phases:

Phase 1: HE4 testing
GP requested CA125 samples sent to MFT for processing over a 16 month period will undergo additional testing for HE4. The study will not interfere with laboratory testing of CA125 and CA125 results will be available to GPs as normal.
Following standard CA125 testing by the laboratory team, samples will be scavenged by a member of the MFT laboratory team and stored at -40 degrees in the MFT laboratory. Samples will be tested in batches on a weekly basis by a lab biochemist using Fujirebio HE4 ELISA kits. Following testing, samples will then be retested on the same day for HE4 on the Fujirebio Lumipulse G600 II machine. Samples will then be disposed of in compliance with MFT laboratory protocols.
If CA125 is within the normal range and HE4 is elevated on the ELISA kit, a letter will be sent by one of the Gynaecological Oncology Medical Secretaries to the patient and their GP, informing them of the result and providing information on the HE4 test. GPs will be asked to discuss the result with the patient and to offer an appointment with Dr Emma Crosbie at St Mary’s for further discussion of the result. Pseudo-anonymised CA125 and HE4 results will be passed to the research team (only the lab and secretarial team will be able to identify patients from this data) as will unlinked hospital trust specific ‘district numbers’, to allow screening in phase 2.

Phase 2: Determination of outcomes
For the 16 months of phase 1 and for an additional 4 months, gynaecology referral lists, clinic lists and MDT records at MFT will be monitored to identify patients, by district number, who underwent CA125 and HE4 testing in phase 1 and who were referred by their GP to gynaecology. Patients with elevated HE4 and normal CA125 who were referred to Dr Emma Crosbie’s clinic in phase 1 will be included. These patients will be approached, wherever possible during clinic appointments or inpatient stays, and consent sought for the study team to perform a search of patient hospital notes. In the event that the patient has been identified in Phase 1 as having a raised CA125 or HE4 but is either being managed in the community or referred to an alternate speciality or hospital, the patient will be contacted by telephone and/or by letter, asking for permission to use their data for research. A consent form and participant information sheet will be sent to the patient with a stamped and addressed envelope to return. This will provide us with consent to search their notes to identify outcome data. Hospital notes will be hand searched to identify predetermined information including presenting symptoms, investigations, surgical outcomes and pathology reports, final diagnosis and cancer stage where applicable. These data will be utilised in biomarker evaluation. Patients who are seen at MFT in phase 2 will be asked to provide another blood sample for research purposes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Specificity of HE4, at different cut off thresholds, alone and in combination with CA125 for ovarian cancer detection in a symptomatic primary care population

Secondary outcome measures

1. Sensitivity of HE4 at different cut off thresholds, alone or in combination with CA125 for ovarian cancer detection in a symptomatic primary care population
2. ELISA versus lumipulse HE4 levels

Overall trial start date

22/07/2017

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Phase 1:
1. Women undergoing GP requested CA125 testing where the sample is processed by MFT
2. Aged over 18

Phase 2:
1. Women who underwent initial CA125 and HE4 testing in phase 1 who are subsequently referred for further tests or treatment
2. Ability to provide informed consent
3. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1200

Participant exclusion criteria

Phase 2:
Inability to provide informed consent

Recruitment start date

03/04/2018

Recruitment end date

03/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Saint Mary's Hospital, Manchester Foundation Trust
M13 0JH

Sponsor information

Organisation

University of Manchester

Sponsor details

1.21a Simon Building
University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellbeing of Women

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists aim to publish their findings in a peer reviewed academic journal. They will also disseminate the results of this study through patient forums, charitable foundations, including Wellbeing of Women, who have funded this study, and through social media. They will present this work at local, national and international academic meetings, depending on the findings, and it will form part of the research thesis of a higher degree at the University of Manchester.

IPD sharing statement
The trialists will make anonymised individual patient data available upon reasonable request for other ethically approved research studies once they have reported their study findings in an academic publication.

Intention to publish date

30/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes