Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409039
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-10
First Post:
2024-04-24
Brief Title:
POLE-END REAL LIFE Endometrial Cancer Early Stages I-II and Advanced Stages III and IV Evaluation of POLE as a Prognostic Factor Participants Are Women 18 Years Old With the Pole Mutation
Sponsor:
Azienda Ulss 2 Marca Trevigiana
Organization:
Azienda Ulss 2 Marca Trevigiana
Study Overview
Official Title:
STUDIO POLE-END REAL LIFE Carcinoma DellEndometrio Stadi Precoci I-II e Avanzati III e IV Valutazione di POLE Come Fattore Prognostico
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLE-END
Brief Summary:
POLE-END is a non-profit observational retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival RFS defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence radiological andor clinical andor histological diagnosis In particular the investigator want to study the influence of the POLE mutation on the survival of patients and therefore on the appearance of relapses by collecting only clinical and anatomopathological-molecular data
The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered
The data will be collected on a specific Data Collection Form made anonymous and sent to the promoting center for final analysis
The study will be conducted according to the attached protocol in compliance with the rules of Good Clinical Practice
The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service Patient enrollment will take place within the centers belonging to the MITO group that have signed up
Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years
As a non-profit studio we request exemption from paying research evaluation costs
The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered
The data will be collected on a specific Data Collection Form made anonymous and sent to the promoting center for final analysis
The study will be conducted according to the attached protocol in compliance with the rules of Good Clinical Practice
The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service Patient enrollment will take place within the centers belonging to the MITO group that have signed up
Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years
As a non-profit studio we request exemption from paying research evaluation costs
Detailed Description:
The molecular classification of endometrial carcinoma and the resulting studies have contributed to the recent ESGOESTROESP guidelines for the management of patients diagnosed with endometrial carcinoma To date however this molecular classification has mostly been performed in the context of clinical trials or in retrospective research contexts and is only now beginning to be implemented in the clinical workflow
Endometrial carcinomas with pathogenic mutations of the POLE gene have demonstrated an excellent clinical outcome in terms of RFS and OS in the early stages of the disease stage I and II especially in high-grade carcinomas Furthermore 3-5 of endometrial carcinomas present multiple molecular alterations In particular the literature suggests that POLE-mutated cases that are at the same time TP53-mutated or MMR-deficient have a clinical behavior like cases with only POLE alteration Overall POLE-mutated tumors would therefore not require adjuvant therapy unlike carcinomas belonging to other molecular groups TP53-mutated MMRd and NSMP or which are attributable to the intermediate-high risk group according to the guidelines The PORTEC-4A study is also underway for this groupIn a cohort of 23 POLE-mutated endometrial carcinomas Stasenko and colleagues documented recurrence in 17 of cases suggesting caution in omitting adjuvant therapy A very recent work on 310 endometrial carcinomas studied from a morpho-molecular perspective including 15 POLE-mutated tumors however has follow-up data that are too short to be conclusive 116 months on average Advanced stage POLE-mutated carcinomas III-IVA are also rare and poorly described in the literature It therefore seems appropriate to prospectively collect real-world clinical-pathological data on a large scale from patients with POLE-mutated tumors with the aim of investigating the histo-molecular characteristics of patients who undergo relapse and being able to compare them with those of non-relapsed patients relapse The relative rarity of POLE-mutated tumors in general and in particular of those that relapse suggests the need to involve multiple centers in order to obtain a significant number
Endometrial carcinomas with pathogenic mutations of the POLE gene have demonstrated an excellent clinical outcome in terms of RFS and OS in the early stages of the disease stage I and II especially in high-grade carcinomas Furthermore 3-5 of endometrial carcinomas present multiple molecular alterations In particular the literature suggests that POLE-mutated cases that are at the same time TP53-mutated or MMR-deficient have a clinical behavior like cases with only POLE alteration Overall POLE-mutated tumors would therefore not require adjuvant therapy unlike carcinomas belonging to other molecular groups TP53-mutated MMRd and NSMP or which are attributable to the intermediate-high risk group according to the guidelines The PORTEC-4A study is also underway for this groupIn a cohort of 23 POLE-mutated endometrial carcinomas Stasenko and colleagues documented recurrence in 17 of cases suggesting caution in omitting adjuvant therapy A very recent work on 310 endometrial carcinomas studied from a morpho-molecular perspective including 15 POLE-mutated tumors however has follow-up data that are too short to be conclusive 116 months on average Advanced stage POLE-mutated carcinomas III-IVA are also rare and poorly described in the literature It therefore seems appropriate to prospectively collect real-world clinical-pathological data on a large scale from patients with POLE-mutated tumors with the aim of investigating the histo-molecular characteristics of patients who undergo relapse and being able to compare them with those of non-relapsed patients relapse The relative rarity of POLE-mutated tumors in general and in particular of those that relapse suggests the need to involve multiple centers in order to obtain a significant number
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None