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

Recruiting

• Conditions: Endometrial Neoplasms; Inflammatory Response
• Interventions: Diagnostic Test: Venous blood sample; Other: Surgical staging of endometrial cancer

• Registration Number: NCT05657483
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

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 Timeline

• Study First Submitted: 2022-12-01
• Study Start: 2022-12-10
• Study First Submitted QC: 2022-12-10
• Study First Posted: 2022-12-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrial cancer patients	Surgical staging of endometrial cancer	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.
Endometrial cancer patients	Venous blood sample	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.

Primary Outcome Measures

Name	Time	Method
Histotype	30 days after surgery	Anatomic pathology report of tissue types that arise during the growth of cancer
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
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

Trial Locations

Locations (1)

Università degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Naples, Italy