Monitoring of precancerous cervical lesions at colposcopy using a new non-invasive technique
| ISRCTN | ISRCTN30282356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30282356 |
| IRAS number | 272534 |
| Secondary identifying numbers | CPMS 44602, IRAS 272534 |
- Submission date
- 13/04/2021
- Registration date
- 27/01/2022
- Last edited
- 15/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study is being done to improve the management of women diagnosed with cervical intraepithelial neoplasia grade 2 (CIN2). Cervical intraepithelial neoplasia is a precancerous condition where abnormal cells grow on the surface of the cervix. CIN 2 means two-thirds of the thickness of the cervical surface layer is affected by abnormal cells. In the past this condition was treated by removal of the disease. However, as we have learnt more about this condition we now know that the majority of these cases resolve spontaneously. This has meant that these women can be offered a watchful waiting approach/expectant management approach. Indeed there has been much work that has now led to clinicians advocating for conservative management. A new non-invasive approach enables doctors to monitor these lesions at a molecular level without the need for a biopsy (tissue sample). This means that such women can be effectively managed in the community without the requirement for an intrusive exam/test.
Who can participate?
Female patients with more than moderate dyskaryosis (change of appearance of the cells that cover the surface of the cervix), between 25 and 35 years of age, with confirmed CIN2 in a single quadrant of the cervix
What does the study involve?
One baseline and up to four further colposcopic examinations during the course of the year. Colposcopy is a procedure to visually examine the cervix using a colposcope. This is one or two additional follow-up examinations in comparison to the normal 6 monthly follow-up appointments for patients who are currently having conservative management for CIN2.
What are the possible benefits and risks of participating?
There are no immediate clinical benefits in this study but the information collected could be used to help decide which women may need treatment in the future. The main disadvantage is a slightly longer procedure (less than 5 minutes) and the two extra visits to the colposcopy clinic for a colposcopic exam. The nitrocellulose absorbent paper is made of material that is perfectly safe to use in humans. There are no other risks in taking part.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2020 to December 2022
Who is funding the study?
The British Society For Colposcopy and Cervical Pathology (BSCCP) (UK)
Who is the main contact?
1. Dr Robin Crawford, robin.crawford@nhs.net
2. Dr Martin Thomas, martin.thomas15@nhs.net
3. Dr Tulay Gulsen, tulay.gulsen@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 |
Principal Investigator
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, Cellular, Management of Care, 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 use the contact details to request a participant information sheet. |
| Scientific title | Monitoring of cervical lesions at colposcopy using a novel non-invasive technique for monitoring of CIN2 lesions (a pilot/feasibility study) |
| Study objectives | The purpose of this study is to examine how best to treat a condition called cervical intraepithelial neoplasia, which is also referred to as CIN2, and is a condition that exists before fully developed cancer cells are formed. The plan is to assess the feasibility of treating CIN2 with watchful waiting rather than surgical treatment. Currently, patients diagnosed with CIN2 are offered the choice of watching and waiting to see what happens as there is more than a 50% chance that the condition will resolve itself without any intervention being necessary. However, up till now, there is no effective way to monitor this condition that isn’t invasive. To improve the way we keep an eye on how this condition is developing, or not, we have a new approach. We plan to offer patients the opportunity to have the top few cells lifted onto a small piece of nitrocellulose paper. This procedure is called cervical cell lift. In the laboratory, technicians are able to analyse the cell lifts so that the cells can be examined in a way that is as near as how they would look inside the body. This approach of keeping the cells together in their natural relationship to other cells on the cervix may be more useful than looking at individual cells. Researchers think this method of examining a cervical cell sample (called a ‘template’) may improve the way they are able to diagnose a patient's condition and monitor whether it is getting better or worse in a more meaningful way. |
| Ethics approval(s) | Approved 04/05/2020, East of England Cambridge & Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)20 797 22545; cambsandherts.rec@hra.nhs.uk), REC ref: 20/EE/0082 |
| Health condition(s) or problem(s) studied | Cervical intraepithelial neoplasia [CIN], grade II |
| Intervention | If enrolled on the study after CIN2 diagnosis: 1. Primary visit for colposcopy – CIN2 identified, acetowhite photograph and Patch taken followed by biopsy 2. 3-month visit for colposcopy – Patch, acetowhite photograph taken and colposcopy done to ensure no change in lesion and comparison with previous photograph of acetowhite change 3. 6-month visit for colposcopy - Patch, acetowhite photograph taken and colposcopy done to ensure no change in lesion and comparison with previous photograph of acetowhite change 4. 9-month visit for colposcopy - Patch, acetowhite photograph taken and colposcopy done to ensure no change in lesion and comparison with previous photograph of acetowhite change 5. 1-year visit for colposcopy – Patch, acetowhite photograph taken and either further biopsy or excisional treatment as per colposcopist impression If enrolled on the study from the pre-existing clinical pathway, participants will start the study at either the 3-month visit (-/+ 2 weeks) or the 6-month routine clinical visit (-/+ 2 weeks) following CIN2 diagnosis. |
| Intervention type | Other |
| Primary outcome measure | 1. CIN2 lesions identified using colposcopy/cytology/histology and cell lift at 0 months (colposcopy cell lift and biopsy), 3 months (colposcopy and cell lift), 6 months (colposcopy, cytology and cell lift), 9 months (colposcopy and cell lift), and 12 months colposcopy cell lift and biopsy) 2. Biomarker patterns consistent with lesion regression/progression identified using immunohistochemistry at 0, 3, 6, 9 and 12 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 04/05/2020 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Upper age limit | 35 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 10; UK Sample Size: 10 |
| Total final enrolment | 14 |
| Key inclusion criteria | All patients who are <35 years of age AND are CIN2 positive on biopsy AND have only single quadrant disease |
| Key exclusion criteria | 1. Patients >35 years 2. Patients who are pregnant 3. Patients who are immunosuppressed/are HIV positive 4. Patients who cannot give informed consent 5. Patients who are allergic to nail varnish/have been told they are allergic to nitrocellulose |
| Date of first enrolment | 07/04/2021 |
| Date of final enrolment | 24/08/2022 |
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
| Phone | +44 (0) 1223 348 005 |
|---|---|
| research@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BSCCP
- 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 | 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 4 | 21/01/2022 | 11/04/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
15/01/2025: The recruitment end date was changed from 30/04/2022 to 24/08/2022.
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.
30/12/2022: Contact details updated.
11/04/2022: The following changes have been made:
1. A protocol file has been uploaded.
2. The final enrolment number has been added.
28/01/2022: Internal review.
13/04/2021: Trial's existence confirmed by the NIHR.
