Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma
NCT ID: NCT03553589
Last Updated: 2018-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2018-10-01
2021-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
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.
Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)
controls
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.
Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)
Interventions
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Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)
Eligibility Criteria
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Inclusion Criteria
* dedifferentiated endometrial cancer
* high grade or low grade endometrial cancer
* benign uterine diseases, e.g. myoma uteri, prolapsed uterus
* prophylactic hysterectomy for Lynch syndrome
Exclusion Criteria
* other types of cancer
* sarcoma uteri
* previous diagnosis of endometrial cancer
* any cancer
* benign ovarian diseases
* previous EC
* pregnancy at the time of enrollment
18 Years
FEMALE
No
Sponsors
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University of Ljubljana, Faculty of Medicine
OTHER
Medical University of Lublin
OTHER
Andrea Romano
OTHER
Responsible Party
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Andrea Romano
PhD. Assistant Professor
Principal Investigators
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Andrea Romano
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Tea Lanišnik Rižner, Prof. Dr.
Role: STUDY_CHAIR
Faculty of Medicine, University of Ljubljana, Slovenia
Locations
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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
Countries
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Central Contacts
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Roy Kruitwagen, Prof. Dr.
Role: CONTACT
Facility Contacts
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Marlies Bongers, Prof. dr.
Role: primary
Related Links
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Related Info
Other Identifiers
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NL63773
Identifier Type: -
Identifier Source: org_study_id
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