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:
- Evaluation about the effectiveness of different treatment modalities;
- Evaluation of outcomes according to different stages of disease;
- 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
-
-
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.
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
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
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.