An observational study in HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation and CIN - Cervical Intraepithelial Neoplasia, sponsored by Lund University. Active, not recruiting at 1 site in Sweden. Open to female participants aged 23 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Lund University · Observational
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.
24 studies on the registry are indexed under Squamous Intraepithelial Lesions; 16 are open to participants now.
Browse Squamous Intraepithelial Lesions studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
They will be selected from a pathology register based on having had a CIN2+ diagnosis.
Inclusion Criteria: (A) Women 23-29 years old with CIN2 who are, according to current guidelines, followed every 6 months with colposcopy for a maximum of 24months. (B) Women 30-70 years old with HSIL in cervical biopsy that have undergone conisation resection (LEEP).
-
Exclusion Criteria: Immunosuppression.
-
Women here have CIN 2 have been followed conservatively
Diagnostic Test: DNA methylation
Women with CIN2+ who have been treated with conization
Diagnostic Test: DNA methylation
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.
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
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
Plan to share: Undecided — It needs to be discussed with ethics committee
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Squamous Intraepithelial Lesions →