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NCT Number: NCT07394413

Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas

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.

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Key information

Conditions

Cervical Adenosarcoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00100, Italy

Location contact

Prof. Nicolò Bizzarri Bizzarri, MD, PhD

CONTACT

[email protected]

0039 0630151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Disease free survival

    Time frame: 5 years

    Disease-free survival is defined as the time from surgery until the first documented recurrence.

  3. Overall survival

    Time frame: 5 years

    Overall survival is measured as the time from surgery to death from any cause,

Secondary outcomes

  1. pregnancy rate

    Time frame: 5 years

    Pregnancy rate is defined as the proportion of patients who achieve a clinically confirmed pregnancy among those attempting conception

  2. live birth rate

    Time frame: 5 years

    Live birth rate is defined as the percentage of pregnancies that result in a live birth.

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Pavone, MD, PhDc

CONTACT

[email protected]

+390630151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: SHAFT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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