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

Endometrial Neoplasms Clinical Trial

— POLE-END  

Official title:

STUDIO POLE-END REAL LIFE: Carcinoma Dell'Endometrio Stadi Precoci I-II e Avanzati III e IV Valutazione di POLE Come Fattore Prognostico

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06409039
• Other study ID #: GRAZIA ARTIOLI
• Status: Enrolling by invitation
• Start date: September 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Azienda Ulss 2 Marca Trevigiana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 and/or clinical and/or 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.

Description:

The molecular classification of endometrial carcinoma and the resulting studies have contributed to the recent ESGO/ESTRO/ESP 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 group.In 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 (11.6 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged > 18 years;

• Histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020;

• Clinical Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation;

• Signing of the informed consent to participate in the study and consent to the processing of personal data.

Exclusion Criteria:

• Patients with endometrial cancer without POLE mutation.

• Patients whose POLE status has been assessed by other methods.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Locations

Country	Name	City	State
Italy	Aulss2 Marca Trevigiana Ospedale Ca Foncello	Treviso	TV
Italy	Aulss2 Marca Trevigiana Ospedale Ca Foncello	Treviso	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ulss 2 Marca Trevigiana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POLE-END REAL LIFE STUDY: endometrial cancer early stages I-II and advanced stages III and IV evaluation of POLE as a prognostic factor	Recurrence-Free Survival (RFS) defined as the time interval between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis),The RFS will be calculated with the Kaplan-Meier method and the 3- and 5-year values will be reported with their 95% confidence intervals, Follow-up data will be collected 3 and 5 years after diagnosis of endometrial cancer,the results will be described by means, medians, standard deviations and interquartile ranges if relating to quantitative variables and by absolute and relative frequencies for qualitative variables.	10 years