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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 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 508

Last updated 2019-11-21

No results posted yet for this study

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

Interventions

DRUG

HPV vaccine

. 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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2019-11-04
Completion
2020-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171505 on ClinicalTrials.gov