Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study

Study Overview
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Brief Summary
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It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines. The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.

Detailed Description
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Surgical treatment for endometrial cancer is class A radical hysterectomy according to Querleu-Morrow and bilateral adnexectomy with systematic pelvic lymphadenectomy. That allows the choice of adjuvant treatment, basing on anatomopathological risk information. Despite the standardization of adjuvant treatments, survival curves are heterogeneous in patients' responses. That is why European guide-lines have proposed a stratification of patients basing on oncological risk and molecular data (Microsatellite instability, aberrant P53, POLE gene mutation). The Investigators want to identify additional parameters to better define risk profiles. Systemic inflammation indices such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and lymphocyte-to-monocyte ratio (LMR) have shown prognostic value in several inflammatory conditions and solid tumors. Therefore, the Investigators have decided to explore their role also in recently diagnosed endometrial cancers, to find correlations with lymphovascular space invasion (LVSI), myometrial infiltration, histotype, and therefore with oncological risk classification. It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines. The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.

Official Title
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Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study

Conditions
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Endometrial Neoplasms, Inflammatory Response

Intervention / Treatment
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* Diagnostic Test: Venous blood sample
* Other: Surgical staging of endometrial cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients histologically diagnosed with endometrial cancer. Patients undergoing surgical staging of the disease. Patients undergoing full-body CT-scan 30 days before enrollment. At least 18-year-old patients. Exclusion Criteria: Unfit to plead. Patients with chronic inflammatory diseases (IBDs; rheumatic conditions). Synchronous tumors or cancer diagnosis in the previous 3 years. Patients undergoing steroid therapy in the last 30 days prior to recruitment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial cancer patients<br>At least 18-year-old patients histologically diagnosed with endometrial cancer who will undergo surgical staging of disease after performing full-body CT-scan 30 days before the enrollment. | Diagnostic Test: Venous blood sample<br>* Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.<br>* Other names: Blood chemistry test;Other: Surgical staging of endometrial cancer<br>* Endometrial, adnexal, and lymphoid tissue samples.<br>* Other names: Biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading | Anatomic pathology report of cell anaplasia in the sampled tumor | 30 days after surgery | 
| Staging | Anatomic pathology report of extent to which the cancer has spread | 30 days after surgery | 
| Histotype | Anatomic pathology report of tissue types that arise during the growth of cancer | 30 days after surgery | 
| Lymphovascular space invasion | Prognostic factor for recurrence and survival in endometrial cancer | 30 days after surgery | 
| Molecular profile | Biomarker testing of genes and/or proteins | 30 days after surgery |