HSIL, High Grade Squamous Intraepithelial LesionNCT07895641
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
An observational study of HSIL, High Grade Squamous Intraepithelial Lesion and DNA Methylation, run by Lund University at 1 site in Sweden.
Trial summary
The goal of this observational study (retrospective cohort study) is to determine whether DNA methylation status in archived cervical cytology samples can predict regression, persistence, or progression of high-grade cervical dysplasia (HSIL/CIN2-3) in women who have previously undergone clinical management and… Read more about this study
- Who is it for?
- Ages 23 to 70 years, women only
- Conditions the study is for
- HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation, CIN - Cervical Intraepithelial Neoplasia
- What is being tested?
- DNA methylation
- How many people
- 199 participants
- Where
- 1 siteSweden
- Study dates
- 19 Sep 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: They will be selected from a pathology register based on having had a CIN2+ diagnosis.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study (retrospective cohort study) is to determine whether DNA methylation status in archived cervical cytology samples can predict regression, persistence, or progression of high-grade cervical dysplasia (HSIL/CIN2-3) in women who have previously undergone clinical management and follow-up.
The main questions it aims to answer are:
Read more
Can methylation status in archived cervical cytology samples predict histologic regression of HSIL (CIN2/3)? Does the addition of clinical factors, screening history, smoking status, and HPV genotype improve the predictive ability of methylation markers for disease regression, persistence, or progression?
Researchers will compare:
Women whose lesions regressed with women whose lesions persisted or progressed. Methylation-positive and methylation-negative samples to assess whether methylation status is associated with subsequent clinical outcomes.
Participants will:
Be identified retrospectively from women aged 23 to 70 years who were previously diagnosed with HSIL/CIN2-3 and managed according to routine clinical practice.
Have archived cervical cytology samples retrieved from biobanks for DNA methylation analysis.
Contribute existing clinical, cytological, histological, and HPV data collected during routine care.
Contribute existing follow-up data from medical records, including outcomes such as regression, persistence, progression, and treatment results.
No additional interventions, testing, or follow-up visits will be performed as part of the study; all analyses will be based on retrospectively collected biological samples and clinical data.
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation, CIN - Cervical Intraepithelial Neoplasia
- Being tested
- DNA methylation
- Keywords
- HSIL, CIN, conization, DNA methylation
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylationDiagnostic test
Index cytological specimen, taken at the time of the HSIL cervical biopsy, will be obtained from the Pathology biobank. Methylation patterns will be analysed from the cytology samples using commercial assays.
| Study group | Role | What they receive |
|---|---|---|
| A: Women under 30 years | Women here have CIN 2 have been followed conservatively Receives: Diagnostic Test: DNA methylation | |
| B: Women over 30 year | Women with CIN2+ who have been treated with conization Receives: Diagnostic Test: DNA methylation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation status (alone) as a predictor of histologic regression of cervical biopsy HSIL (CIN2/3) in cone specimen (Part A) and as a predictor of histologic regression of cervical HSIL (CIN2) within 24 months of follow-up
Measured: 6 months
Secondary outcomes (1)
The added predictive value of clinical variables (age, smoking status, screening history) and HPV genotype (HPV16 vs non-16) when combined with methylation status for predicting HSIL regression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start19 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSIL, High Grade Squamous Intraepithelial LesionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skåne Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895641
- Sponsor's protocol ID
- 2025-03966-01
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It needs to be discussed with ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT07895641
- Acronym / sponsor ID
- 2025-03966-01
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation, CIN - Cervical Intraepithelial Neoplasia
- Keywords
- HSIL, CIN, conization, DNA methylation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skåne Sweden
- Study start
- 19 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study (retrospective cohort study) is to determine whether DNA methylation status in archived cervical cytology samples can predict regression, persistence, or progression of high-grade cervical dysplasia (HSIL/CIN2-3) in women who have previously undergone clinical management and follow-up.
The main questions it aims to answer are:
Can methylation status in archived cervical cytology samples predict histologic regression of HSIL (CIN2/3)? Does the addition of clinical factors, screening history, smoking status, and HPV genotype improve the predictive ability of methylation markers for disease regression, persistence, or progression?
Researchers will compare:
Women whose lesions regressed with women whose lesions persisted or progressed. Methylation-positive and methylation-negative samples to assess whether methylation status is associated with subsequent clinical outcomes.
Participants will:
Be identified retrospectively from women aged 23 to 70 years who were previously diagnosed with HSIL/CIN2-3 and managed according to routine clinical practice.
Have archived cervical cytology samples retrieved from biobanks for DNA methylation analysis.
Contribute existing clinical, cytological, histological, and HPV data collected during routine care.
Contribute existing follow-up data from medical records, including outcomes such as regression, persistence, progression, and treatment results.
No additional interventions, testing, or follow-up visits will be performed as part of the study; all analyses will be based on retrospectively collected biological samples and clinical data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Women under 30 years | – | Diagnostic Test: DNA methylationWomen here have CIN 2 have been followed conservatively |
| B: Women over 30 year | – | Diagnostic Test: DNA methylationWomen with CIN2+ who have been treated with conization |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- They will be selected from a pathology register based on having had a CIN2+ diagnosis.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA methylationIndex cytological specimen, taken at the time of the HSIL cervical biopsy, will be obtained from the Pathology biobank. Methylation patterns will be analysed from the cytology samples using commercial assays. | Diagnostic test | A: Women under 30 years, B: Women over 30 year |
Primary outcome
Methylation status (alone) as a predictor of histologic regression of cervical biopsy HSIL (CIN2/3) in cone specimen (Part A) and as a predictor of histologic regression of cervical HSIL (CIN2) within 24 months of follow-up
Time frame: 6 months
1 secondary outcome
The added predictive value of clinical variables (age, smoking status, screening history) and HPV genotype (HPV16 vs non-16) when combined with methylation status for predicting HSIL regression
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided. It needs to be discussed with ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HSIL, High Grade Squamous Intraepithelial Lesion and DNA Methylation, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylation status (alone) as a predictor of histologic regression of cervical biopsy HSIL (CIN2/3) in cone specimen (Part A) and as a predictor of histologic regression of cervical HSIL (CIN2) within 24 months of follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.