Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma (BioEndoCar)

Andrea Romano

Status: Unknown

Conditions: Endometrial Cancer

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03553589

NL63773

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 2 patient 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.

Treatment:

Other: Blood sampling

controls

Description:

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.

Treatment:

Other: Blood sampling