Collection of cervical cells at colposcopy using a novel technique for analysis of high-risk vs low-risk lesions
| ISRCTN | ISRCTN13994246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13994246 |
| Secondary identifying numbers | CPMS 44798, IRAS 224794 |
- Submission date
- 07/04/2021
- Registration date
- 14/09/2021
- Last edited
- 15/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
The aim of this study is to improve the collection and analysis of cells taken from the surface of the cervix (neck of the womb) in order to more accurately identify cervical disease when it is present.
Who can participate?
Women aged 25 to 65 years with screen-detected abnormal cervical cytology varying from mild dyskaryosis to severe dyskaryosis (change of appearance in cells that cover the surface of the cervix)
What does the study involve?
Cells taken from the surface of the cervix are currently sampled using a cytobrush or spatula as part of the cervical smear test. This approach scrapes and/or scarifies the surface of the cervix and harvests a mixture of cells from the superficial to mid epithelial layers. The researchers propose a modified approach in which cells are taken from the surface of the cervix using a ‘filter paper disk of nylon or cellulose. In the modified approach, the disk of nylon or cellulose will be gently pressed onto the surface of the cervix in order to lift off a layer of exfoliating surface cells. The morphology (shape, structure, form, and size) of the surface cells is indicative of underlying cervical disease, and this can then be assessed by cytological analysis.
What are the possible benefits and risks of participating?
There are no immediate clinical benefits in this study but the information obtained could be used to better inform which women may need treatment in the future. Apart from a slightly longer procedure, (less than 5 minutes), there are no risks in taking part.
Where is the study run from?
Addenbrookes Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2017 to April 2023
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Robin Crawford, robin.crawford@nhs.net
Contact information
Scientific
Chief Investigator
Cambridge University Hospitals NHS Foundation Trust
Box 242
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216251 |
|---|---|
| robin.crawford@nhs.net |
Scientific
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust
Box 242
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216251 |
|---|---|
| robin.crawford@nhs.net |
Scientific
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust
Box 242
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216251 |
|---|---|
| mas202@cam.ac.uk |
Scientific
Senior Clinical Trial Coordinator
Cambridge University Hospitals NHS Foundation Trust
Box 242
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 349707 |
|---|---|
| martin.thomas15@nhs.net |
Scientific
Clinical Trial Coordinator
Cambridge University Hospitals NHS Foundation Trust
Box 242
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 256364 |
|---|---|
| tulay.gulsen@nhs.net |
Study information
| Study design | Non-randomized; Both; Design type: Screening, Active Monitoring, Clinical Laboratory Study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please contact the study coordinator to request a participant information sheet. |
| Scientific title | Collection of cervical cells at colposcopy using a novel technique for analysis of high-risk vs low-risk lesions |
| Study hypothesis | The aim of the project is to improve the collection and analysis of cells taken from the surface of the cervix in order to identify more accurately high-risk cervical pathology when it is present. Patients attending colposcopy who are undergoing assessment for an abnormal smear will be asked to take part. At the start of the examination, a photograph of the cervix will be taken. Then a disc of material (nitrocellulose) designed to collect cells will be applied to the cervix for 15 seconds and then removed and fixed for analysis. There are a number of potential advantages: 1. Reduced need for biopsy 2. Aid localisation of high-risk vs low-risk lesions 3. Ultimately lead to more patient-focused treatment with a reduction in the need for Loop treatments and thus reducing the morbidity associated with this |
| Ethics approval(s) | Approved 04/05/2017, Oxford B Ethics Committee, South Central Region (South Central – Oxford B Research Ethics Committee, Whitefriars, Level 3, Block B, Lewin’s Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8046; oxfordb.rec@hra.nhs.uk), REC ref: 17/SC/0203 |
| Condition | Cervical cancer |
| Intervention | The patient will be invited to take part in the study. The woman will have been informed that there is an active research programme in the colposcopy clinic. Following consent with the study nurse, the patient will discuss her case with the colposcopist. When the woman is ready for the colposcopy, a digital photograph of the cervix will be taken after the removal of the cervical mucus with a cotton bud (takes less than 10 seconds the system is set up to take colpophotographs). The filter disc is applied to the surface of the cervix for 15 seconds with mild pressure (no discomfort for the patient). The disc is removed and stored in transport medium. The standard colposcopic examination then begins with the application of an acetic acid solution. A further colpophotograph is taken. Biopsies or treatment as per the underlying disease are performed as required. Correlation between the two photographs, the colposcopist's opinion and the histology will be made with the disc. The researchers aim to recruit 2-3 patients per week and aim for a mixture of patients with referral for high-grade and low-grade abnormalities. |
| Intervention type | Other |
| Primary outcome measure | Correlation between high-risk and low-risk cervical disease identified using the filter disc and by the standard method |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 07/06/2017 |
| Overall study end date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 387; UK Sample Size: 387 |
| Total final enrolment | 764 |
| Participant inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2, Female, aged 25 years or above 3. Diagnosed with abnormal cervical cytology by routine screening |
| Participant exclusion criteria | 1. Participant is unable to give consent 2. Pregnant 3. HIV/systemic Immunosuppression |
| Recruitment start date | 12/10/2017 |
| Recruitment end date | 30/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Additional files are not available to upload but please contact the study coordinator to request the protocol if necessary. Planned publication in a high-impact peer-reviewed journal in 2022/2023. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 7 | 21/02/2022 | 11/04/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
15/01/2025: The total final enrolment was changed from 14 to 764.
14/06/2024: The following changes were made to the study record:
1. Contact details updated.
2. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
3. Total final enrolment added.
11/04/2022: A protocol file has been uploaded.
07/04/2021: Trial's existence confirmed by the NIHR.
