Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma
- Conditions
- Endometrial Cancer
- Interventions
- Other: Blood sampling
- Registration Number
- NCT03553589
- Lead Sponsor
- Andrea Romano
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases Blood sampling Women older than 18 years and diagnosed with endometrial cancer will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. controls Blood sampling Women older than 18 years and with a benign endometrial disturbance will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses.
- Primary Outcome Measures
Name Time Method Creation of a diagnostic algorithm 2020-2021 Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive diagnostic algorithms based on blood metabolites, proteins and clinical data. Algorithms in the biomarker discovery study will be developed by comparing EC and patients with benign uterine pathologies.
- Secondary Outcome Measures
Name Time Method Creation of a prognostic algorithm 2021 Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive prognostic algorithms based on blood metabolites, proteins, clinical data at baseline and follow up information. Algorithms in the biomarker discovery study will be developed by comparing EC patients with low risk and high risk for cancer progression and recurrence.
Trial Locations
- Locations (5)
University Medical Centre, Ljubljana
馃嚫馃嚠Ljubljana, Slovenia
Maastricht University Medical Centre
馃嚦馃嚤Maastricht, Netherlands
Maxima Medical Centre
馃嚦馃嚤Veldhoven, Netherlands
Lublin Medical University
馃嚨馃嚤Lublin, Poland
Faculty of Medicine, University of Ljubljana
馃嚫馃嚠Ljubljana, Slovenia