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.

NCT04171505 | Unknown FDA Drug

• 1 other identifier: ISM-190623
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervix, Dysplasia; HPV Infection; HPV Vaccine; Cervix Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

vaccinated women

* 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.

Drug: HPV vaccine

non vaccinated woman

* 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.

Interventions

HPV vaccine DRUG

. Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission. We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account.

vaccinated women

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Related Publications (6)

• 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):264-8. doi: 10.1016/j.ygyno.2013.04.050. Epub 2013 Apr 26.

  PMID: 23623831 RESULT

• 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. doi: 10.1056/NEJMoa061741.

  PMID: 17494925 RESULT

• 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 Sep 6. No abstract available.

  PMID: 30197061 RESULT

• 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. doi: 10.1007/s00404-018-4926-y. Epub 2018 Oct 10.

  PMID: 30306310 RESULT

• 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: 10.1080/13697137.2019.1600500. Epub 2019 Apr 29.

  PMID: 31030590 RESULT

• Paavonen 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.

  PMID: 19586656 RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

ANDREA CASAJUANA PÉREZ

CONTACT

0034 913 30 30 01; andreamercedes.casajuana@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PLUVIO CORONADO MARTÍN

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 4, 2019
• Primary Completion: November 4, 2019
• Study Completion: December 1, 2020
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)