Assessing regression of cervical precancerous lesions and risk factors
Regression of Cervical Precancerous Lesions and Associated Risk Factors
This study is testing how well certain treatments help women with severe cervical precancerous lesions get better and if there are specific factors that can predict their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | General University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT06147388 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the histopathological regression of severe cervical precancerous lesions (CIN 2 and CIN 3) and the normalization of HPV tests and cytology findings in patients treated conservatively or through conization. Patients will undergo colposcopic evaluations every four months, with biopsies performed to assess regression or persistence of lesions. The study will also identify predictive factors associated with regression and propose a model to predict the likelihood of lesion regression based on the collected data.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 years with bioptically verified CIN 2 or CIN 3 lesions.
Not a fit: Patients with a history of cervical cancer, invasive lesions, or those who are immunosuppressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who may avoid unnecessary surgical interventions for cervical precancerous lesions.
How similar studies have performed: Previous studies have indicated that a significant proportion of CIN 2 and CIN 3 lesions can spontaneously regress, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. squamocolumnar junction fully visualized 2. bioptically verified CIN 2 or CIN 3 3. age ≥ 18 years 4. age ≤ 40 years 5. informed consent Exclusion Criteria: 1. squamocolumnar junction not fully visualized 2. suspicion on glandular lesion 3. suspicion on invasive cancer 4. personal history of CIN 2, 3 or cerv. cancer 5. gravidity 6. HIV positivity 7. immunosuppression 8. impossible photographic documentation
Where this trial is running
Prague
- General University Hospital — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Lukas Dostalek
- Email: lukas.dostalek@vfn.cz
- Phone: +420224967451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.