NCT06611020

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2020Jan 2027

Study Start

First participant enrolled

January 1, 2020

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5.1 years

First QC Date

September 20, 2024

Last Update Submit

September 25, 2024

Conditions

Cervical Intraepithelial Neoplasia

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

  • HPV recurrence

    2 years

Study Arms (1)

treatment of HPV-related disease with or without vaccination

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pateints with HPV-related disease

You may qualify if:

  • Treatment of HPV-related disease

You may not qualify if:

  • Previous HPV vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20148, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Grazia Casadei, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Bogani, ph.d.

CONTACT

651-296-9676giorgiobogani@yahoo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

January 1, 2020

Primary Completion

January 31, 2025

Study Completion (Estimated)

January 31, 2027

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations

IT(2)