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
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.
Study Type
Observational
Primary Outcome
Creation of a diagnostic algorithm
Secondary Outcome
Creation of a prognostic algorithm
Condition
Endometrial Cancer
Intervention
Blood sampling
Study Arms / Comparison Groups
Cases
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
400
Start Date
October 1, 2018
Completion Date
June 1, 2021
Primary Completion Date
June 1, 2021
Eligibility Criteria
Inclusion Criteria Cases:
- endometrioid, serous, clear cell or mucinous endometrial cancer
- dedifferentiated endometrial cancer
- high grade or low grade endometrial cancer
Inclusion Criteria Controls:
- benign uterine diseases, e.g. myoma uteri, prolapsed uterus
- prophylactic hysterectomy for Lynch syndrome
Exclusion Criteria Cases:
- atypical hyperplasia
- other types of cancer
- sarcoma uteri
- previous diagnosis of endometrial cancer
Exclusion Criteria Controls:
- any cancer
- benign ovarian diseases
- previous EC
- pregnancy at the time of enrollment
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Romano, +31 433881286, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03553589
Organization ID
NL63773
Responsible Party
Sponsor-Investigator
Study Sponsor
Andrea Romano
Collaborators
University of Ljubljana, Faculty of Medicine
Study Sponsor
Andrea Romano, Principal Investigator, Maastricht University Medical Centre
Verification Date
December 2018