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

University of Campania "Luigi Vanvitelli"

Status: Enrolling

Conditions: Inflammatory Response; Endometrial Neoplasms

Treatments: Diagnostic Test: Venous blood sample; Other: Surgical staging of endometrial cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05657483

0035563/i

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 1 patient group

Endometrial cancer patients

Description:

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.

Treatment:

Other: Surgical staging of endometrial cancer

Diagnostic Test: Venous blood sample