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

NCT ID: NCT05657483

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-10
• Study Completion Date: 2024-12-10

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.

Conditions

Endometrial Neoplasms; Inflammatory Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Venous blood sample

Intervention Type: DIAGNOSTIC_TEST

Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.

Surgical staging of endometrial cancer

Intervention Type: OTHER

Endometrial, adnexal, and lymphoid tissue samples.

Interventions

Venous blood sample

Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.

Intervention Type: DIAGNOSTIC_TEST

Surgical staging of endometrial cancer

Endometrial, adnexal, and lymphoid tissue samples.

Intervention Type: OTHER

Other Intervention Names

Blood chemistry test; Biopsy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Carlo Ronsini

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Ronsini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Università degli Studi della Campania Luigi Vanvitelli

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Ronsini, MD

Role: CONTACT

carlo.ronsini90@gmail.com

+393277334102

Facility Contacts

Carlo Ronsini, MD

Role: primary

carlo.ronsini@unicampania.it

3277334102

Other Identifiers

0035563/i

Identifier Type: -

Identifier Source: org_study_id