Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma

Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma: A Pilot Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05273099

Enrollment

Registered

2022-03-10

Start date

2022-03-01

Completion date

2023-12-31

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Endometrium

Keywords

biomarkers, cancer gene mutations, endometrial cancer

Brief summary

Endometrial carcinoma represents the most common gynaecological cancer and the sixth most frequent cancer among women worldwide. The 5-year survival of patients with stage I endometrial carcinoma is 75%-88% versus 50% for stage III or 15% for stage IV disease. Therefore, early detection could improve survival rates. Specifically, in the most prevalent, type 1 endometrial cancer develops from hyperplastic endometrium. The aim of the study was to evaluate the utility of cancer gene mutations from endometrial biopsies towards predicting synchronous or metachronous development of malignant lesions. The aim of the study was to evaluate whether endometrial biopsies could already carry mutations in cancer genes useful for predicting or anticipating subsequent cancer development

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age \> 18 years old * patients subjected to endometrial biopsies with previous histopathologically negative and subsequent histopathologically positive for endometrial carcinoma * patient informed consent

Exclusion criteria

\- Endometrial carcinoma patients without a previous non-tumour biopsy were excluded

Design outcomes

Primary

Measure	Time frame	Description
Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer	1 year	Mutation analyses performed on DNA isolated from formalin fixed, paraffin embedded samples retrieved for each patient by sequencing a panel of fifty genes (ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL) both on non-cancerous biopsies and on matched endometrial carcinoma biopsies.

Secondary

Measure	Time frame	Description
Integration of molecular results with clinico pathological data	1 year	Integration of molecular results with clinico pathological data

Countries

Italy

Contacts

Primary ContactGennaro Scutiero, MD

gennaro.scutiero@unife.it+390532236657

Outcome results