Cervical AdenosarcomaSHAFTNCT07394413
Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas
An observational study of Cervical Adenosarcoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Despite a growing body of literature on the subject, there is still uncertainty regarding direct comparisons between different conservative surgical techniques for cervical adenocarcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Adenosarcoma
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2026to 1 Feb 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult women of reproductive age with cervical adenocarcinoma undergoing fertility-sparing surgery (conization, simple trachelectomy, radical trachelectomy) between 01/06/2019 and 30/06/2024
Who may be able to join
- Adult women of reproductive age with a diagnosis of cervical adenocarcinoma
- Undergoing fertility-sparing surgery
- Minimum 12-month follow-up
- Signed informed consent
Who cannot join
- Histotypes other than cervical adenocarcinoma
- Undergoing radical surgery
- Follow-up less than 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00100
Prof. Nicolò Bizzarri Bizzarri, MD, PhD, 0039 0630151, nicolo.bizzarri@policlinicogemelli.it
About this study
Despite a growing body of literature on the subject, there is still uncertainty regarding direct comparisons between different conservative surgical techniques for cervical adenocarcinomas. In particular, it remains unclear whether fertility-sparing surgery for cervical adenocarcinomas - characterized by skip lesions - can ensure optimal disease control while achieving adequate obstetric outcomes.
For this reason, a systematic review and meta-analysis of the literature, along with an analysis of our center's data, is warranted. This approach will allow a critical, comparative evaluation of the efficacy of the different techniques (conization, simple trachelectomy, and radical trachelectomy) and the identification of prognostic factors to guide therapeutic choice.
- Conditions
- Cervical Adenosarcoma
- Keywords
- cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The recurrence rate is defined as the proportion of patients who develop disease recurrence confirmed by imaging or histopathologic evaluation after FSS.
Measured: 5 years
Disease free survival
Disease-free survival is defined as the time from surgery until the first documented recurrence.
Measured: 5 years
Overall survival
Overall survival is measured as the time from surgery to death from any cause,
Measured: 5 years
Secondary outcomes (2)
pregnancy rate
Pregnancy rate is defined as the proportion of patients who achieve a clinically confirmed pregnancy among those attempting conception
Measured: 5 years
live birth rate
Live birth rate is defined as the percentage of pregnancies that result in a live birth.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical AdenosarcomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolò Bizzarri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394413
- Sponsor's protocol ID
- 7939
- Acronym
- SHAFT
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas
- ClinicalTrials.gov ID
- NCT07394413
- Acronym / sponsor ID
- SHAFT / 7939
- Conditions
- Cervical Adenosarcoma
- Keywords
- cervical cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
Despite a growing body of literature on the subject, there is still uncertainty regarding direct comparisons between different conservative surgical techniques for cervical adenocarcinomas. In particular, it remains unclear whether fertility-sparing surgery for cervical adenocarcinomas - characterized by skip lesions - can ensure optimal disease control while achieving adequate obstetric outcomes.
For this reason, a systematic review and meta-analysis of the literature, along with an analysis of our center's data, is warranted. This approach will allow a critical, comparative evaluation of the efficacy of the different techniques (conization, simple trachelectomy, and radical trachelectomy) and the identification of prognostic factors to guide therapeutic choice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women of reproductive age with cervical adenocarcinoma undergoing fertility-sparing surgery (conization, simple trachelectomy, radical trachelectomy) between 01/06/2019 and 30/06/2024
Key inclusion criteria (4 listed)
- Adult women of reproductive age with a diagnosis of cervical adenocarcinoma
- Undergoing fertility-sparing surgery
- Minimum 12-month follow-up
- Signed informed consent
Key exclusion criteria (3 listed)
- Histotypes other than cervical adenocarcinoma
- Undergoing radical surgery
- Follow-up less than 12 months
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
Recurrence rate
Time frame: 5 years
The recurrence rate is defined as the proportion of patients who develop disease recurrence confirmed by imaging or histopathologic evaluation after FSS.
Disease free survival
Time frame: 5 years
Disease-free survival is defined as the time from surgery until the first documented recurrence.
Overall survival
Time frame: 5 years
Overall survival is measured as the time from surgery to death from any cause,
2 secondary outcomes
pregnancy rate
Time frame: 5 years
live birth rate
Time frame: 5 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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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.
Nicolò Bizzarri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Adenosarcoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Matteo Pavone, MD, PhDc (+390630151, matteo.pavone@guest.policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.