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

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Response; Endometrial Neoplasms
• Intervention / Treatment: Diagnostic test: Venous blood sample; Other: Surgical staging of endometrial cancer

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 Type: Observational
• Enrollment (Estimated): 128

Contacts and Locations

• Study Contact: Name: Carlo Ronsini, MD; Phone Number: +393277334102; Email: carlo.ronsini90@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80138
    • Recruiting
    • Università degli Studi della Campania Luigi Vanvitelli
    • Contact: Carlo Ronsini, MD; Phone Number: 3277334102; Email: carlo.ronsini@unicampania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histological diagnosis of endometrial cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: Blood chemistry test; Other: Surgical staging of endometrial cancer; Endometrial, adnexal, and lymphoid tissue samples.; Other Names: Biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Carlo Ronsini, MD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: 0035563/i

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No