Clinical trial NCT05657483: Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
Official title: Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Neoplasms
Inflammatory Response
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Grading
timeFrame: 30 days after surgery
measure: Staging
timeFrame: 30 days after surgery
measure: Histotype
timeFrame: 30 days after surgery
measure: Lymphovascular space invasion
timeFrame: 30 days after surgery
measure: Molecular profile
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Carlo Ronsini, MD
role: PRINCIPAL_INVESTIGATOR
References: