Adjuvant VaccInation After Conization for the Treatment f... | NCT06611020

Studies
Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia

NCT06611020

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

Recruiting

Last Update Posted

Sep 26, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Cervical Intraepithelial Neoplasia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jan 31, 2027Estimated

First Submitted Date

Sep 20, 2024

First Submission Date that Met QC Criteria

Sep 20, 2024

First Posted Date

Sep 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2024

Last Update Posted Date

Sep 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valentina Chiappa, md, Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Label	Type	Description	Intervention Names
treatment of HPV-related disease with or without vaccination

Measure	Description	Time Frame
HPV recurrence		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment of HPV-related disease

Exclusion Criteria:

Previous HPV vaccination

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pateints with HPV-related disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giorgio Bogani, ph.d.	Contact	651-296-9676		giorgiobogani@yahoo.it

Overall Officials

Name	Affiliation	Role
Grazia Casadei, MD	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Istituto Nazionale dei Tumori	Recruiting	Milan	Lombardy	20148	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40277212	Derived	Caia C, De Maria F, Sopracordevole F, Ciavattini A, Casarin J, Ghezzi F, Vizzielli G, Chiappa V, Leone Roberti Maggiore U, Valsecchi C, Scambia G, Raspagliesi F, Corso G, Bogani G. Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia. Eur J Cancer Prev. 2026 May 1;35(3):243-249. doi: 10.1097/CEJ.0000000000000971. Epub 2025 Apr 18.

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases