Clinical trial · Observational
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women. Research Objectives: * Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk). * Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients. * Evaluate spontaneous regression/progression over two years based on methylation results. * Assess spontaneous regression/progression over two years based on CinTec plus results.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Conservative Management | — | UNRESOLVED | — |
| Risk Factors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Unvaccinated
- description
- Without adjuvant vaccination for HPV
- label
- Vaccinated
- description
- Adjuvantly vaccinated against HPV with Gardasil-9
Primary outcomes (3)
- measure
- To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
- timeFrame
- 2 year follow up
- description
- Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping
- measure
- To evaluate spontaneous regression/progression over a 2-year period according to methylation results
- timeFrame
- 2 year follow up
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 46 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent * cervical biopsy - HG lesion * Age: 18-46 years * colposcopicaly visible transformation zone * HPV: Unvaccinated * cytology all except AIS, adenocarcinoma, squamous cell carcinoma, AGC NEO Exclusion Criteria: * cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma * immunosuppression * active autoimmune disease * history of cervical cryodestruction * HPV vaccinated prior to start of the study
References
Publications (3)
- BACKGROUNDLee MH, Finlayson SJ, Gukova K, Hanley G, Miller D, Sadownik LA. Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women. J Low Genit Tract Dis. 2018 Jul;22(3):212-218. doi: 10.1097/LGT.0000000000000399. PMID 29762428
- BACKGROUNDKyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kalliala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633. doi: 10.1136/bmj.i3633. PMID 27469988
- BACKGROUNDDepuydt CE, Jonckheere J, Berth M, Salembier GM, Vereecken AJ, Bogers JJ. Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections. Cancer Med. 2015 Aug;4(8):1294-302. doi: 10.1002/cam4.473. Epub 2015 May 20. PMID 25991420