Fertility-sparing in Early-stage Cervcial Cancer: The ETE... | NCT06351228

Studies
Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project

NCT06351228

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

Unknown status

Last Update Posted

Apr 8, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Conization plus nodal evaluation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 2, 2024

First Submission Date that Met QC Criteria

Apr 2, 2024

First Posted Date

Apr 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conization plus nodal evaluation	Other	Conization plus nodal evaluation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women with early stage cervical cancer undegoing uterine preserving surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano		Milan	Lombardy	20133	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39955179	Derived	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques