Biomarkers for ovarian cancer risk assessment
| ISRCTN | ISRCTN13470572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13470572 |
| Integrated Research Application System (IRAS) | 218202 |
| Protocol serial number | IRAS 218202 |
| Sponsor | University of Manchester |
| Funder | Wellbeing of Women |
- Submission date
- 08/06/2018
- Registration date
- 13/06/2018
- Last edited
- 31/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Chloe Barr
Scientific
Scientific
5th Floor Research Office
Saint Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Dr Emma Crosbie
Scientific
Scientific
5th Floor Research Office
Saint Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational case series pilot study |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study |
| Study objectives | 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(s) | HRA: South Central - Oxford B Research Ethics Committee, 21/12/2017, ref: 17/SC/0667 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Specificity of HE4, at different cut off thresholds, alone and in combination with CA125 for ovarian cancer detection in a symptomatic primary care population |
| Key secondary outcome measure(s) |
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 |
| Completion date | 05/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1200 |
| Total final enrolment | 1375 |
| Key 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 |
| Key exclusion criteria | Phase 2: Inability to provide informed consent |
| Date of first enrolment | 03/04/2018 |
| Date of final enrolment | 03/08/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Saint Mary's Hospital, Manchester Foundation Trust
M13 0JH
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/04/2022 | 04/07/2022 | Yes | No | |
| Results article | 09/05/2021 | 31/08/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/08/2022: Publication reference added.
04/07/2022: Publication reference added.
17/03/2022: The intention to publish date has been changed from 01/09/2021 to 01/08/2022.
26/04/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/11/2019 to 05/03/2021.
2. The intention to publish date has been changed from 30/11/2020 to 01/09/2021.
3. The total final enrolment number has been added.
05/03/2019: Cancer Research UK lay summary link added to plain English summary field.
