NCT06351228

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 8, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

April 2, 2024

Last Update Submit

April 2, 2024

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • oncological outcomes

    disease-free survival

    3-yrs

Interventions

Conization plus nodal evaluationOTHER

Conization plus nodal evaluation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with early stage cervical cancer undegoing uterine preserving surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Lombardy, 20133, Italy

Location

Related Publications (1)

  • Bogani G, Scambia G, Malzoni M, Casarin J, Vizzielli G, Amant F, Raspagliesi F; Investigators of the ETERNITY Project. Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project. Int J Gynecol Cancer. 2025 Apr;35(4):101643. doi: 10.1016/j.ijgc.2025.101643. Epub 2025 Jan 17.

    PMID: 39955179DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Conization

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

March 30, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 8, 2024

Record last verified: 2024-03

Locations

IT(1)