Predictors of Node Positivity in Endometrial Cancer
Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2022
CompletedFirst Submitted
Initial submission to the registry
March 4, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 19, 2024
August 1, 2024
3 years
March 4, 2023
September 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
positive nodes
positive nodes detected by sentinel node mappinig
12 months
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- Stage IVB endoemtrial cancer
- consent withdraw
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20148, Italy
Related Publications (1)
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.
PMID: 38658017DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giorgio Bogani, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 4, 2023
First Posted
March 31, 2023
Study Start
January 10, 2022
Primary Completion
December 31, 2024
Study Completion
January 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share