Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07394413

Acronym

SHAFT

Enrollment

100

Registered

2026-02-06

Start date

2026-02-01

Completion date

2027-02-01

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Adenosarcoma

Keywords

cervical cancer

Brief 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. 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult women of reproductive age with a diagnosis of cervical adenocarcinoma * Undergoing fertility-sparing surgery * Minimum 12-month follow-up * Signed informed consent

Exclusion criteria

* Histotypes other than cervical adenocarcinoma * Undergoing radical surgery * Follow-up less than 12 months

Design outcomes

Primary

Measure	Time frame	Description
Recurrence rate	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	5 years	Disease-free survival is defined as the time from surgery until the first documented recurrence.
Overall survival	5 years	Overall survival is measured as the time from surgery to death from any cause,

Secondary

Measure	Time frame	Description
pregnancy rate	5 years	Pregnancy rate is defined as the proportion of patients who achieve a clinically confirmed pregnancy among those attempting conception
live birth rate	5 years	Live birth rate is defined as the percentage of pregnancies that result in a live birth.

Countries

Italy

Contacts

CONTACTMatteo Pavone, MD, PhDc

matteo.pavone@guest.policlinicogemelli.it+390630151

PRINCIPAL_INVESTIGATORNicolò Bizzarri

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Outcome results