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Clinical Trials/NCT05657483
NCT05657483
Recruiting
Not Applicable

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

University of Campania "Luigi Vanvitelli"1 site in 1 country128 target enrollmentDecember 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Neoplasms
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
128
Locations
1
Primary Endpoint
Histotype
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2022
End Date
December 10, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlo Ronsini

Medical Doctor

University of Campania "Luigi Vanvitelli"

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

Outcomes

Primary Outcomes

Histotype

Time Frame: 30 days after surgery

Anatomic pathology report of tissue types that arise during the growth of cancer

Grading

Time Frame: 30 days after surgery

Anatomic pathology report of cell anaplasia in the sampled tumor

Staging

Time Frame: 30 days after surgery

Anatomic pathology report of extent to which the cancer has spread

Lymphovascular space invasion

Time Frame: 30 days after surgery

Prognostic factor for recurrence and survival in endometrial cancer

Molecular profile

Time Frame: 30 days after surgery

Biomarker testing of genes and/or proteins

Study Sites (1)

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