Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma

Endometrial Cancer Clinical Trial

— BioEndoCar  

Official title:

Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553589
• Other study ID #: NL63773
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2018
• Source: Academisch Ziekenhuis Maastricht
• Contact: Andrea Romano, Dr.
• Phone: +31 433881286
• Email: a.romano[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• Blood sampling
Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Maxima Medical Centre	Veldhoven
Poland	Lublin Medical University	Lublin
Slovenia	Faculty of Medicine, University of Ljubljana	Ljubljana
Slovenia	University Medical Centre, Ljubljana	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
Andrea Romano	Medical University of Lublin, University of Ljubljana, Faculty of Medicine

Countries where clinical trial is conducted

Netherlands,  Poland,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a diagnostic algorithm	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.	2020-2021
Secondary	Creation of a prognostic algorithm	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.	2021

External Links

•   Link