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. (VENUS)

November 19, 2019 updated by: ANDREA CASAJUANA, Hospital San Carlos, Madrid

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital (Madrid) between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-linked disease will be evaluated. For this purpose, the percentage of lesional 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. The data will be obtained through the review of clinical records.

Our protocol is explained above:

HPV detection method:

The detection of HPV is performed on a liquid basis by means of the CLARK PAPILOMAVIRUS HUMAN test that detects the presence of the HPV virus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71.72, 73, 81, 82, 83, 84, 85 and 89). The test has a diagnostic sensitivity of 98.2% and a diagnostic specificity of 100% and analytical specificity: 100%. The analytical sensitivity of this test is 100% when the number of copies is 1,000 or 10,000 depending on the type of HPV. The Laboratory has carried out external quality control of the SEAP.

Pre-surgical evaluation:

Those patients with an abnormal cytological result and / or positive HPV tests were referred to the PTGI consultations of Clínico San Carlos Hospital for evaluation according to the Cervical Cancer Prevention Guidelines issued by the Spanish Association of Cervical Pathology and Colposcopy (AEPCC) in 2006 and 2014. These patients underwent colposcopy with biopsy if necessary +/- determination of HPV. 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.

Surgical treatment:

Excisional therapy was performed in the operating room on a scheduled basis under local analgesia and sedation. After infiltration with local anesthetic and vasoconstrictor in the 4 quadrants of the cervix, excisional therapy with diathermic loop is performed under colposcopy control, obtaining the piece in a single specimen. The piece is oriented with a long thread at 12:00 h, it is introduced in formaldehyde and send to pathological anatomy for deferred study. In all cases, immediate endocervical curettage post-treatment was performed.

Clinical follow-up:

The first revision is made 30 days after surgery where patient is informed of histological results and the date on first control post-treatment based on the diagnosis.

Following the protocol of the AEPCC, in case of non-involvement of margins and negative endocervical curettage, the patient comes after 6 months from the intervention to perform the first post-surgery control with co-test. In case of positive endocervical curettage or margin involvement, the first post-surgery control will be performed at 4 months with cotest + endocervical study and colposcopy. Persistent disease is defined as the presence of cytological alteration and / or HPV infection in the first post control performed at 4-6 months after excisional therapy. These patients are excluded from the study, since only those in which both tests are negative will be included.

Subsequently, a new co-test was performed at 12 months, 24 months and 36 months after the first post-surgery control. After 3 years of negative testing, the patient is returned to the current cervical cancer-screening program.

Study Type

Observational

Enrollment (Anticipated)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Time Frame
Age, type of virus, degree of injury, variables related to demographic and histological data of the patient, date of 1st dose of vaccine.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISM-190623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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