Evaluating the use of DNA methylation as a tool for cervical cancer screening in sub-Saharan Africa
| ISRCTN | ISRCTN17152893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17152893 |
| Secondary identifying numbers | 23789/001 |
- Submission date
- 30/10/2025
- Registration date
- 01/11/2025
- Last edited
- 31/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cervical cancer is one of the most common and preventable cancers among women worldwide, yet it remains a leading cause of cancer death in sub-Saharan Africa. Effective screening can detect precancerous changes before they progress to cancer, but current screening methods, including cytology and HPV testing, have limitations in low-resource settings due to infrastructure, workforce, and access challenges.
The WID-qCIN test is a new DNA methylation-based test designed to detect changes in cervical cells that indicate the presence of precancer (CIN2/3) or cancer. It can be performed on the same sample used for HPV testing, including self-collected swabs. This study aims to evaluate the diagnostic performance of the WID-qCIN test for identifying cervical precancer and cancer in women in Nigeria, and to assess its feasibility as part of a screening programme in low- and middle-income countries.
Who can participate?
Women aged 25–65 years attending cervical cancer screening or colposcopy clinics at one of three participating hospitals in Nigeria. Participants must be able to give informed consent. Women are excluded if they are pregnant, have had a hysterectomy, a history of cervical or endometrial cancer, previous pelvic radiotherapy, or have received treatment for cervical intraepithelial neoplasia (CIN) in the last six months.
What does the study involve?
This is a multicentre prospective diagnostic accuracy study. After providing informed consent, participants complete a short questionnaire on demographic and medical history, followed by a pelvic examination to collect a cervical sample for cytology and research testing. All participants then undergo colposcopy, and a cervical biopsy is obtained for histology, which serves as the reference standard.
The research sample will be tested for high-risk HPV and analysed using the WID-qCIN DNA methylation test. The results will be compared with cytology, colposcopy, and histology findings to determine the sensitivity, specificity, and overall diagnostic accuracy of WID-qCIN as a triage test for HPV-positive women.
What are the possible benefits and risks of participating?
There is no direct clinical benefit to participants, but their involvement will contribute to improving cervical cancer screening in Nigeria and other low-resource settings. All procedures are routine in cervical screening and carry minimal risk, such as mild discomfort or spotting after examination or biopsy.
Where is the study run from?
The study is coordinated by University College London (UCL), London UK, in collaboration with University College Hospital, Ibadan, Nigeria, Lagos University Teaching Hospital, Nigeria, and Jos University Teaching Hospital, Nigeria.
When is the study starting and how long is it expected to run for?
Recruitment began in 2023 and is expected to conclude in 2025.
Who is funding the study?
Funding is provided by University College London (global engagement funds), Land Tirol (through its funding for the European Translational Oncology Prevention and Screening (EUTOPS) institute) and HCA healthcare UK.
Who is the main contact?
Dr Ojone Illah
University College London
o.illah@ucl.ac.uk
Contact information
Principal investigator
University College London
Institute for Women's Health
74 Huntley Street
London
WC1E 6AU
United Kingdom
| Phone | +44 2076792000 |
|---|---|
| m.widschwendter@ucl.ac.uk |
Principal investigator
University College London
Institute for Women's Health
74 Huntley Street
London
WC1E 6AU
United Kingdom
| Phone | +44 2076792000 |
|---|---|
| a.olaitan@ucl.ac.uk |
Public, Scientific
University College London
Institute for Women's Health
74 Huntley Street
London
WC1E 6AU
United Kingdom
 ORCID ID |
0000-0002-7322-2427 |
|---|---|
| Phone | +44 2076792000 |
| o.illah@ucl.ac.uk |
Study information
| Study design | Multicentre prospective cross-sectional diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Diagnostic performance of a DNA methylation-based test for cervical cancer screening in Nigerian women |
| Study acronym | PECCAN |
| Study objectives | Assess the diagnostic performance of the WID™-qCIN test as a triage tool for the detection of premalignant and malignant cervical disease in a population of Nigerian women. |
| Ethics approval(s) |
1. Approved 31/05/2022, Nigeria Health Research Ethics Committee (NHREC) (Department of Health Planning, Research and Statistics, Federal Ministry of Health, 11th Floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way, Abuja, -, Nigeria; +234 95238367; chairman@nhrec.net), ref: NHREC/01/01/2007 2. Approved 23/02/2022, UCL Research Ethics Committee (Research Ethics Service Office of the Vice-Provost (Research, Innovation & Global Engagement) University College London, London, WC1E 6BT, United Kingdom; +44 (0) 20 7679 2000; ethics@ucl.ac.uk), ref: 23789/001 3. Approved 04/07/2022, University of Ibadan/University College Hospital Ibadan (INSTITUTE FOR ADVANCED MEDICAL RESEARCH AND TRAINING (IAMRAT), College of Medicine, University of Ibadan, Ibadan, -, Nigeria; +234 8023268431; uiuchec@gmail.com), ref: UI/EC/22/0243 4. Approved 27/04/2022, Jos University Teaching Hospital Research Ethical Committee (Jos University Teaching Hospital, Lamingo, Jos 930241 Plateau State, Jos, -, Nigeria; +234 903 0001194; juthjos@gmail.com), ref: UTH/DCS/REC/127/XXXI/279 5. Approved 30/06/2022, Lagos University Teaching Hospital Health Research Ethics Committee (Room 107, 1stFloor, LUTH Administrative Block, Lagos University Teaching Hospital Ishaga Road, Idi-Araba 102215, Lagos, -, Nigeria; +234 15850737; luthethics@yahoo.com), ref: ADM/DCST/HREC/APP/5095 |
| Health condition(s) or problem(s) studied | Screening for cervical cancer |
| Intervention | All participants provided a cervical sample for HPV and WID-qCIN DNA methylation testing, underwent cytology, colposcopy, and biopsy for histological confirmation. No therapeutic intervention was administered as part of the study. |
| Intervention type | Other |
| Primary outcome measure | Diagnostic accuracy of the WID-qCIN DNA methylation test for the detection of CIN3+, using histologically confirmed CIN3 or invasive cervical cancer as the reference standard. Measured via cytology analysis and colposcopic assessment conducted at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. |
| Secondary outcome measures | 1. Diagnostic accuracy (sensitivity and specificity) of cytology and colposcopy for the detection of CIN3+, compared with histology as the reference standard. Measured via cytology analysis and colposcopic assessment conducted at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. 2. Diagnostic accuracy (sensitivity and specificity) of HPV 16/18 and the composite WID-qCIN/HPV 16/18 test for the detection of CIN3+, compared with histology as the reference standard. Measured via HPV genotyping and WID-qCIN DNA methylation testing on participant samples collected at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. 3. Comparative performance of WID-qCIN vs cytology and colposcopy as triage tools in hrHPV- positive women. Measured as sensitivity and specificity with 95% confidence intervals following completion of laboratory analysis on all participant samples. 4. Distribution of hrHPV subtypes in the study population. Measured via HPV genotype testing on participant samples collected at baseline. |
| Overall study start date | 01/02/2022 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 100 |
| Total final enrolment | 182 |
| Key inclusion criteria | 1. Women aged 25–65 years 2. Able and willing to provide written informed consent |
| Key exclusion criteria | 1. Current pregnancy. 2. History of hysterectomy, cervical or endometrial cancer, or pelvic radiotherapy. 3. Treatment for cervical intraepithelial neoplasia (CIN) within the preceeding six months. 4. Participants receiving ablative treatment at the time of colposcopy (precluding histological sampling). |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 18/02/2025 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
Ibadan
N/A
Nigeria
Plateau State
Jos
N/A
Nigeria
Lagos, Nigeria
Lagos
N/A
Nigeria
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 2076792000 |
|---|---|
| ethics@ucl.ac.uk | |
| Website | https://www.ucl.ac.uk |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- Province of the Tyrol, Tiroler Wissenschaftsfonds
- Location
- Austria
Government organisation / For-profit companies (industry)
- Alternative name(s)
- HCA Healthcare, Inc., HCA Healthcare Inc, HCA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| 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 peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
30/10/2025: Trial's existence confirmed by UCL ethics committee.
