Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma

NCT05273099 | Unknown

• 1 other identifier: 170578
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer of Endometrium

Keywords

biomarkers; cancer gene mutations; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer

  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.

  1 year

Secondary Outcomes (1)

• Integration of molecular results with clinico pathological data

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with endometrial cancer and previous negative endometrial sample.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy

Ferrara, Italy

RECRUITING

Related Publications (4)

• Bakkum-Gamez JN, Wentzensen N, Maurer MJ, Hawthorne KM, Voss JS, Kroneman TN, Famuyide AO, Clayton AC, Halling KC, Kerr SE, Cliby WA, Dowdy SC, Kipp BR, Mariani A, Oberg AL, Podratz KC, Shridhar V, Sherman ME. Detection of endometrial cancer via molecular analysis of DNA collected with vaginal tampons. Gynecol Oncol. 2015 Apr;137(1):14-22. doi: 10.1016/j.ygyno.2015.01.552. Epub 2015 Feb 10.

  PMID: 25677060 BACKGROUND

• Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

  PMID: 23636398 BACKGROUND

• Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

  PMID: 24840647 BACKGROUND

• Suhaimi SS, Ab Mutalib NS, Jamal R. Understanding Molecular Landscape of Endometrial Cancer through Next Generation Sequencing: What We Have Learned so Far? Front Pharmacol. 2016 Nov 1;7:409. doi: 10.3389/fphar.2016.00409. eCollection 2016.

  PMID: 27847479 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Endometrium sample

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

• Gennaro Scutiero, MD

  Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gennaro Scutiero, MD

CONTACT

+390532236657; gennaro.scutiero@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)