Cervical Intraepithelial NeoplasiaVITALNCT06611020
Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia
An observational study of Cervical Intraepithelial Neoplasia, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- How many people
- 600 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2020to 31 Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pateints with HPV-related disease
Who may be able to join
- Treatment of HPV-related disease
Who cannot join
- Previous HPV vaccination
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20148
Giorgio Bogani, md, +393803933116, giorgiobogani@yahoo.it
Valentina Chiappa, MD, 3803933116
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20148
Giorgio Bogani, +393803933116, giorgiobogani@yahoo.it
About this study
Official title: The Role of Adjuvant VaccInation After Conization for the Treatment for Cervical Dysplasia
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
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- HPV
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| treatment of HPV-related disease with or without vaccination | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jan 2020
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Chiappa, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Grazia Casadei, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611020
- Sponsor's protocol ID
- 570/20
- Acronym
- VITAL
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40277212
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adjuvant VaccInation After Conization for the Treatment for Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT06611020
- Acronym / sponsor ID
- VITAL / 570/20
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- HPV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment of HPV-related disease with or without vaccination | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pateints with HPV-related disease
Key inclusion criteria (1 listed)
- Treatment of HPV-related disease
Key exclusion criteria (1 listed)
- Previous HPV vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV recurrence
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 40277212Caia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grazia Casadei, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Bogani, ph.d. (651-296-9676, giorgiobogani@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.