Predictors of Node Positivity in Endometrial Cancer | NCT05793333

Studies
Predictors of Node Positivity in Endometrial Cancer

NCT05793333

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Endometrial Cancer

Interventions

Not provided

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Mar 4, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Mar 31, 2023Actual

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

Sep 15, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valentina Chiappa, Dr, Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive nodes	positive nodes detected by sentinel node mappinig	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Histologically confirmed endometrila cancer
Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
Data on histological characteristics of the ttumor
Execution of sentinel node mapping
Data on sentinel node status (negative vs. positive)

Exclusion Criteria:

Stage IVB endoemtrial cancer
consent withdraw

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping.

After the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice).

We will correlate those data with findings achieved by sentinel nodes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grazia M Casadei, ph.d.	Contact	917-275-6975		grazia.casadei@istitutotumori.mi.it

Overall Officials

Name	Affiliation	Role
Giorgio Bogani, MD	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Istituto Nazionale dei Tumori	Recruiting	Milan	Lombardy	20148	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38658017	Derived	Bogani G, Lalli L, Casarin J, Ghezzi F, Chiappa V, Fanfani F, Scambia G, Raspagliesi F. Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial. Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416.

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