Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas

NCT07394413 | Not Yet Recruiting DMC

• 1 other identifier: 7939
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Adenosarcoma

Keywords

cervical cancer

Outcome Measures

Primary Outcomes (3)

• Recurrence rate

  The recurrence rate is defined as the proportion of patients who develop disease recurrence confirmed by imaging or histopathologic evaluation after FSS.

  5 years

• Disease free survival

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

  5 years

• Overall survival

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

  5 years

Secondary Outcomes (2)

• pregnancy rate

  5 years

• live birth rate

  5 years

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00100, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicolò Bizzarri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Pavone, MD, PhDc

CONTACT

+390630151; matteo.pavone@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IT (1)