Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project (Eternity)

April 2, 2024 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Outcomes of Early-stage Cervcial Cancer Patients Sheduled to Have Fertility-sparing Approach: The ETERNITY Project

The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.

The primary aim is to report outcomes of those patients.

Other aims included:

  1. Evaluation about the effectiveness of different treatment modalities;
  2. Evaluation of outcomes according to different stages of disease;
  3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women with early stage cervical cancer undegoing uterine preserving surgery

Description

Inclusion Criteria:

  • Histological confirmed cervical cancer
  • FIGO Stage IA1-IB3
  • Fertility-sparing (conization plus nodal dissection)

Exclusion Criteria:

  • age less than 18 yrs
  • age more than 50 yrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oncological outcomes
Time Frame: 3-yrs
disease-free survival
3-yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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