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Brief Title: Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma
Official Title: Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer
Study ID: NCT03553589
Brief Summary: Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects. In the present study, the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.
Detailed Description: Rationale: Endometrial cancer (EC) is the most frequent gynaecological malignancy in the developed world. Optimal treatment of EC depends on early diagnostics and pre-operative stratification to appropriately select the extent of surgery and to plan further therapeutic approach. Currently, invasive endometrial histology is the gold standard for diagnosis, as there are no valid non-invasive methods available, and patient stratification is based on histopathology and surgical findings. There is a great need for efficient and reliable screening test for asymptomatic women with high risk of EC including Lynch syndrome patients and tamoxifen treated patients. In addition, a prognostic test is needed to stratify pre-operatively EC patients with high risk of progression in need of radical surgery together with adjuvant chemo/ratio therapy from EC patients with good prognosis. In this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of EC. Objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Maastricht University Medical Centre, Maastricht, , Netherlands
Maxima Medical Centre, Veldhoven, , Netherlands
Lublin Medical University, Lublin, , Poland
Faculty of Medicine, University of Ljubljana, Ljubljana, , Slovenia
University Medical Centre, Ljubljana, Ljubljana, , Slovenia
Name: Andrea Romano
Affiliation: Maastricht University Medical Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Tea Lanišnik Rižner, Prof. Dr.
Affiliation: Faculty of Medicine, University of Ljubljana, Slovenia
Role: STUDY_CHAIR