UnknownNot Applicable

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.

Spain508 participantsStarted 2019-11-04

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence

Timeframe: 2 years

Trial details

NCT IDNCT04171505

SponsorHospital San Carlos, Madrid

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-04

Contact for this trial

ANDREA CASAJUANA PÉREZ

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

View on ClinicalTrials.gov More Cervix, Dysplasia trials