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

NCT06409039 | Enrolling By Invitation

• 1 other identifier: GRAZIA ARTIOLI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female Patients aged \> 18 years with histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020. Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation.

You may qualify if:

• 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.

You may not qualify if:

• Patients with endometrial cancer without POLE mutation.
• Patients whose POLE status has been assessed by other methods.

Sponsors & Collaborators

• Azienda Ulss 2 Marca Trevigiana: lead

Study Sites (2)

Aulss2 Marca Trevigiana Ospedale Ca Foncello

Treviso, TV, 31100, Italy

Location

Aulss2 Marca Trevigiana Ospedale Ca Foncello

Treviso, Veneto, 31100, Italy

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• GRAZIA ARTIOLI

  AULSS2 MARCA TREVIGIANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 10, 2024
• Study Start: September 4, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

IT (2)