Menu
Not yet recruiting NCT07394413

Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas

Observational Cervical Adenosarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Adenosarcoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Recurrence rate [Time frame: 5 years]
  • Disease free survival [Time frame: 5 years]
  • Overall survival [Time frame: 5 years]
Secondary outcome measures (2)
  • pregnancy rate [Time frame: 5 years]
  • live birth rate [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Identifiers

NCT: NCT07394413 · 7939

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗