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Tracking Recurrence of HPV-Related Lesions After Surgery and Vaccination in Women

Observes women with HPV-related genital lesions to find what predicts their lesions returning after treatment.

Key facts

Who runs it
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Where
Milan, ItalySee the site
Trial code
Registry title
Multimodality Treatments of HPV-related Lesions of the Female Genital Tract
Status
Recruiting
People taking part
200 people, planned
Started
15 Jul 2020
Expected to end
30 Dec 2028
Type of study
Observational
Treatments tested
  • vaccination
Record updated
9 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with HPV-related disease of the cervix or vagina. It studies how surgery and HPV vaccination affect the chance that lesions come back.

Age
18 years or older
Sex
Women only
Disease stage
HPV-related disease of the female genital tract (cervix and vagina)

Main reasons for not taking part

  • People who withdraw their consent

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Patients with HPV related disease

Who cannot take part

  • consent withdrawal

Where in Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di MilanoMilan, ItalyContact: Giorgio BoganiTaking people

About the trial

What the trial wants to find out

Cervical cancer is one of the most preventable types of cancer, as it develops over an extended period, and its causative agent is well-known. Persistent infection with human papillomavirus (HPV) is the primary factor causing cervical cancer. Generally, persistent HPV infection leads to cervical dysplasia (also known as cervical intraepithelial neoplasia), which can potentially progress to cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women remain at risk of developing cervical dysplasia. Women with cervical dysplasia who receive appropriate follow-up and treatment are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Furthermore, recurrent cervical dysplasia can contribute to morbidity, as additional surgical treatments are associated with fertility and obstetric complications in women who wish to preserve their childbearing potential. Against this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance.

Read full original descriptionShow less

The management of residual or recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent or recurrent dysplasia following initial treatment. Assessing these risk categories is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our research group has estimated the risk of developing persistent or recurrent dysplasia in several investigations, identifying positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence as key prognostic factors. Our findings align with a substantial body of literature investigating this issue. However, accurately estimating the risk of persistent or recurrent dysplasia for each individual patient remains challenging.

Similarly, few studies have evaluated the outcomes of patients affected by vaginal intraepithelial neoplasia, and results have been inconsistent. In fact, there is no consensus on the optimal treatment modality for these patients. Treatments have included topical applications of imiquimod or 5-fluorouracil (5-FU), as well as ablative and excisional procedures performed via conventional surgery, electrosurgery, and carbon dioxide laser. The risk of developing invasive vaginal cancer in these patients remains uncertain, with estimates ranging between 2% and 12% in different series. Recently, a multi-institutional Italian study reported that more than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia were found to have occult invasive vaginal cancer at the time of excisional procedures, highlighting the need for histological diagnosis before proceeding with ablative or medical treatments. Additionally, the widespread implementation of HPV vaccination is expected to reduce the risk of recurrence after treatment.

In this context, the investigators aim to evaluate the significance of post-treatment HPV vaccination and other prognostic factors in influencing the risk of persistent or recurrent lesions of the uterine cervix and vagina.

The group in the trial

  • Patients with HPV-related disease

    Patients with HPV-related disease including cervical and vaginal lesions

    Treatment: vaccination

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Predictors of Recurrence After Treatment (Surgery Plus Vaccination) of HPV-related Disease of the Female Genital Tract
Plain-language title
Tracking Recurrence of HPV-Related Lesions After Surgery and Vaccination in WomenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 May 2025