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Trial Title:
A Retrospective Study on Multiple Classifier Endometrial Cancer
NCT ID:
NCT05976113
Condition:
Uterine Cancer
Conditions: Official terms:
Endometrial Neoplasms
Uterine Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Observation only
Description:
Just obsrevation following standard of care (including surgery, chemotherapy and
radiation when appropriate)
Arm group label:
Patients with multiple classifier endometrial cancer
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria were the following: (i) histological diagnosis of endometrial cancer;
(ii) execution of hysterectomy (with or without salpingo-oophorectomy) with or without
nodal dissection; (iii) apparent early-stage disease; (iv) conventional pathological
evaluation; and (v) molecular/genomic evaluation of the disease (including at least POLE
sequencing, MMR protein immunostaining or MSI assessment, p53 immunostaining or TP53
sequencing). Exclusion criteria were: (i) consent withdrawal, (ii) execution of
neoadjuvant therapy, and (iii) stage IV disease.
Gender:
Female
Gender based:
Yes
Gender description:
patients with uterine cancers
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giorgio Bogani
Phone:
3803933116
Email:
giorgiobogani@yahoo.it
Start date:
July 27, 2023
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976113
