Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia (VITAL)

September 25, 2024 updated by: Valentina Chiappa, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

The Role of Adjuvant VaccInation After Conization for the Treatment for Cervical Dysplasia

HPV vaccination has emerged as a strategy to reduce the risk of recurrence oafter excisional treatment. However, only few data are aviable. In this trial the investigators aim to assess the role of HPV vaccination in women traeted for HPV-related lesions

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients treated for HPV-related disease are counseled about the potential protective role of HPV vaccination. The investigators will monitor the risk of HPV recurrence in pateints who choce to have vaccination and who did not.

Study Type

Observational

Enrollment (Estimated)

600

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

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20148
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pateints with HPV-related disease

Description

Inclusion Criteria:

  • Treatment of HPV-related disease

Exclusion Criteria:

  • Previous HPV vaccination

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

Cohorts and Interventions

Group / Cohort
treatment of HPV-related disease with or without vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HPV recurrence
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Grazia Casadei, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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)

January 1, 2020

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 570/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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