Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Endometrial cancer patients 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
Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.
Other Names:
Other: Surgical staging of endometrial cancer
Endometrial, adnexal, and lymphoid tissue samples.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Grading [30 days after surgery]
Anatomic pathology report of cell anaplasia in the sampled tumor
- Staging [30 days after surgery]
Anatomic pathology report of extent to which the cancer has spread
- Histotype [30 days after surgery]
Anatomic pathology report of tissue types that arise during the growth of cancer
- Lymphovascular space invasion [30 days after surgery]
Prognostic factor for recurrence and survival in endometrial cancer
- Molecular profile [30 days after surgery]
Biomarker testing of genes and/or proteins
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients histologically diagnosed with endometrial cancer.
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Patients undergoing surgical staging of the disease.
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Patients undergoing full-body CT-scan 30 days before enrollment.
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At least 18-year-old patients.
Exclusion Criteria:
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Unfit to plead.
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Patients with chronic inflammatory diseases (IBDs; rheumatic conditions).
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Synchronous tumors or cancer diagnosis in the previous 3 years.
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Patients undergoing steroid therapy in the last 30 days prior to recruitment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Università degli Studi della Campania Luigi Vanvitelli | Naples | Italy | 80138 |
Sponsors and Collaborators
- University of Campania "Luigi Vanvitelli"
Investigators
- Principal Investigator: Carlo Ronsini, MD, University of Campania "Luigi Vanvitelli"
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0035563/i