Clinical trial · Observational
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
Retrospective Cohort Study to Analyze Whether Prophylactic Vaccination Against HPV Can Reduce the Risk of Recurrence in Women Who Have Received an Excisional Therapy for HSIL / CIN2-3. Recurrence is Defined as the Detection of Infection by the Same HPV Genotype for at Least 6-12 Months (Persistent Infection), and / or Cytological Alteration and / or Cervical and / or Vaginal Histological Lesion of Any Grade (SIL / CIN / VaIN) in Patients With Negative Cotest in the First Post Control.
- 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)
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015. It will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration. Inclusion criteria: * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have received HPV vaccination and provide vaccination card. Exclusion criteria: * Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study. * Patients treated by an indication other than HSIL/CIN. * Patients under immunosuppression conditions.
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 |
|---|---|---|---|
| Cervix, Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervix Lesion | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| HPV Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- vaccinated women
- description
- * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have received HPV vaccination and provide vaccination card.
- interventionNames
- Drug: HPV vaccine
- label
- non vaccinated woman
- description
- * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have NOT received HPV vaccination and provide vaccination card.
Primary outcomes (1)
- measure
- Recurrence
- timeFrame
- 2 years
- description
- defined as the existence of persistent HPV infection and / or presence of cytological abnormality and / or presence of SIL / CIN / VaIN of any grade.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. * Women who sign informed consent. * Patients with negative results in the first post-surgery control. * Patients who have received HPV vaccination and provide vaccination card. Exclusion Criteria: * Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study. * Patients treated by an indication other than HSIL/CIN. * Patients under immunosuppression conditions.
References
Publications (6)
- RESULTKang WD, Choi HS, Kim SM. Is vaccination with quadrivalent HPV vaccine after loop electrosurgical excision procedure effective in preventing recurrence in patients with high-grade cervical intraepithelial neoplasia (CIN2-3)? Gynecol Oncol. 2013 Aug;130(2):264-8. doi: 10.1016/j.ygyno.2013.04.050. Epub 2013 Apr 26. PMID 23623831
- RESULTFUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741. PMID 17494925
- RESULTGhelardi A, Parazzini F, Martella F, Pieralli A, Bay P, Tonetti A, Svelato A, Bertacca G, Lombardi S, Joura EA. SPERANZA project: HPV vaccination after treatment for CIN2. Gynecol Oncol. 2018 Nov;151(2):229-234. doi: 10.1016/j.ygyno.2018.08.033. Epub 2018 Sep 6. No abstract available. PMID 30197061
- RESULTPieralli A, Bianchi C, Auzzi N, Fallani MG, Bussani C, Fambrini M, Cariti G, Scarselli G, Petraglia F, Ghelardi A. Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease. Arch Gynecol Obstet. 2018 Dec;298(6):1205-1210. doi: 10.1007/s00404-018-4926-y. Epub 2018 Oct 10. PMID 30306310
- RESULTVelentzis LS, Brotherton JML, Canfell K. Recurrent disease after treatment for cervical pre-cancer: determining whether prophylactic HPV vaccination could play a role in prevention of secondary lesions. Climacteric. 2019 Dec;22(6):596-602. doi: 10.1080/13697137.2019.1600500. Epub 2019 Apr 29. PMID 31030590
- RESULTPaavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.