Treatments of HPV-related Lesions

Cervical Cancer Clinical Trial

Official title:

Predictors of Recurrence After Treatment of HPV-related Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05938192
• Other study ID #: 572020
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Giorgio Bogani
• Phone: 3803933116
• Email: giorgiobogani[@]yahoo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the recent years, the widespread adoption of primary and secondary preventions has dramatically reduced the incidence of cervical cancer in developed countries. However, cervical cancer still represents a major health concern, being the third most common malignancy among women aged <39 years, and the second most common cause of death for cancer among females between 20 and 39 years in the United States.

Cervical cancer is one of the most preventable types of cancer, since it develops over a long time and the causative agent has been recognized. Persistent infection from human papillomavirus (HPV) is the main factor causing cervical cancer. Generally, persistent HPV infection causes cervical dysplasia (also known as cervical intraepithelial neoplasia), which potentially evolves in cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women is at risk of developing cervical dysplasia. Women with cervical dysplasia who have appropriate follow-up and treatments are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Additionally, recurrent cervical dysplasia might be cause of morbidity since adjunctive surgical treatments are associated with fertility and obstetrical issues in women who wish to preserve their childbearing potential. With this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance.

However, the management of residual/recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent/recurrent dysplasia after primary treatment. Assessing these classes of risks is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our study group estimated the risk of developing persistent/recurrent dysplasia in several investigations, observing that positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence are the main prognostic factors. Our data corroborated a considerable body of literature investigating this issue. However, it is difficult to estimate the risk of developing persistent/recurrent dysplasia for each patient.

Similarly, few investigations evaluated outcomes of patientsaffected by vaginal intraepithelial neoplasia with discor-dant results. In fact, there is no consensus on the optimaltreatment modality for those patients. Treatments in-cluded: topical application of imiquimod or 5-fluorouracil(5-FU), as well as ablative and excisional proceduresexecuted via conventional surgery, electrosurgery andcarbon dioxide LASER. The risk of developinginvasive vaginal cancer in those patients remains unclear,ranging between 2% and 12% in different series.Recently, a multi-institutional Italian study reports thatmore than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia are detected withoccult invasive vaginal cancer at the time of excisionalprocedure, thus suggesting the need to achieve a histologi-cal diagnosis before proceeding to ablative or medicaltreatments Here, we aim to evaluate the importance of various prognostic factors in influencing the risk of persistent/recurrent lesions of the uterine cervix and the vagina

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with HPV related disease

Exclusion Criteria:

• consent withdrawal

Related Conditions & MeSH terms

• Cervical Cancer
• Cervix Lesion
• HPV
• Vaginal Diseases

Intervention

Procedure:
• LASER surgery
Patients will have laser surgery for managing HPV-related lesions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival	time between surgery and first recurrence	36 months