Clinical trial NCT05273099: Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma
Official title: Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Endometrium
Keywords: biomarkers
cancer gene mutations
endometrial cancer
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with endometrial cancer and previous negative endometrial sample.

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


Eligibility criteria: 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

Primary outcomes:
measure: Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer
timeFrame: 1 year
Secondary outcomes:
measure: Integration of molecular results with clinico pathological data
timeFrame: 1 year
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Study officials:
affiliation: Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
name: Gennaro Scutiero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.