HPV Infection Clinical Trial
— VENUSOfficial title:
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.
NCT number | NCT04171505 |
Other study ID # | ISM-190623 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 4, 2019 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 508 |
Est. completion date | December 2020 |
Est. primary completion date | November 4, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico San Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital San Carlos, Madrid | Merck Sharp & Dohme Corp. |
Spain,
FUTURE 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. — View Citation
Ghelardi 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 — View Citation
Kang 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) — View Citation
Paavonen J, Naud P, Salmerón 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 — View Citation
Pieralli 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 — View Citation
Velentzis 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: 10.1080/13 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | defined as the existence of persistent HPV infection and / or presence of cytological abnormality and / or presence of SIL / CIN / VaIN of any grade. | 2 years | |
Secondary | Age, type of virus, degree of injury, variables related to demographic and histological data of the patient, date of 1st dose of vaccine. | 2 years |
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