A Retrospective Study on Multiple Classifier Endometrial Cancer

NCT05976113 | Unknown

• 1 other identifier: 1402020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer is not a single entity but rather a very heterogeneous group of diseases. Historically, endometrial cancer patients have been classified as endometrioid (type I) or non-endometrioid (type II) according to the dualistic Bokhman model- However, this approach has been limited in accurately predicting prognosis and guiding treatment owing to heterogeneity within subtypes, inadequate incorporation of molecular and genetic information, and high interobserver variability . In the last ten years, after the publication of The Cancer Genome Atlas (TCGA)\[5\], the molecular classification of endometrial cancer into four molecular subtypes \[(i) POLE/ultramutated group (POLE mutated), (ii) mismatch repair deficiency/microsatellite-instable, hypermutated group (MMRd/MSI-H), (iii) copy-number-high, TP53-mutant (CNH/p53abn), and (iv) copy-number-low, TP53-wild-type (CNL, or No Specific Mutational Profile \[NSMP\])\] has rapidly gained interest. Recently, the European Societies of Gynaecological Oncology, Radiotherapy and Oncology, and Pathology (ESGO-ESTRO-ESP), the European Society of Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), and the new 2023 International Federation of Gynecology and Obstetrics (FIGO) staging system have promoted the use of (surrogate) molecular classification. Retrospective studies supported the value of adopting molecular classification to offer reliable data on prognostication and adjuvant treatment decisions. Although no prospective data are available, current guidelines promote the use of molecular profiles to tailor adjuvant treatment after surgery. As only a few retrospective studies have investigated the association between molecular profiles and response to various adjuvant treatments, it is important to note that data are limited. Interestingly, the growing adoption of molecular profiling led to the detection of a subgroup of tumors called multiple classifiers, characterized by multiple (two or three) molecular features. According to the guidelines, tumors with a POLE mutation should be considered POLEmut, regardless of other molecular features, whereas MMRd/MSI-H tumors with a p53 abnormality should be considered MMRd/MSI-H. Data on these patients is limited and fragmentary. The aforementioned consensus is based solely on a large retrospective cohort of multiple classifiers collected by Leon-Castillo et al.. Hence, to fill this literature gap, the investigators designed this retrospective study, which aimed to collect multiple classifiers patients to improve knowledge on this emerging category.

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  24 months

Study Arms (1)

Patients with multiple classifier endometrial cancer

Endometrial cancer patients who have two or more molecular features

Other: Observation only

Interventions

Observation only OTHER

Just obsrevation following standard of care (including surgery, chemotherapy and radiation when appropriate)

Patients with multiple classifier endometrial cancer

Eligibility Criteria

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

Study Population

This is a retrospective study with patients diagnosed with multiple classifier endometrial cancer Data of consecutive patients treated between June 1, 2019, and January 31, 2023, were collected.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Neoplasms

Condition Hierarchy (Ancestors)

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: July 27, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-07

Locations

IT (1)