Multimodality Treatments of HPV-related Lesions of the Female Genital Tract

NCT05938192 | Recruiting DMC

• 1 other identifier: 572020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

HPV; Cervical Cancer; Cervix Lesion; Vagina Disease

Keywords

hpv

Outcome Measures

Primary Outcomes (1)

• recurrence-free survival

  time between surgery and first recurrence

  36 months

Study Arms (1)

Patients with HPV-related disease

Patients with HPV-related disease including cervical and vaginal lesions

Procedure: vaccination

Interventions

vaccination PROCEDURE

Patients will have surgery (followed by vaccination) for managing HPV-related lesions

Patients with HPV-related disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with newly histological diagnosed moderate /severe dysplasia of the uterine cervix and vagina .

You may qualify if:

• Patients with HPV related disease

You may not qualify if:

• consent withdrawal

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Lombardy, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaginal Diseases; Papillomavirus Infections

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Giorgio Bogani

  Giorgio Bogani

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Bogani, md

CONTACT

917-275-6975; giorgiobogani@yahoo.it

Giorgio Bogani

CONTACT

917-275-6975; giorgiobogani@yahoo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 10, 2023
• Study Start: July 15, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 9, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)