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

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657483
• Other study ID #: 0035563/i
• Status: Recruiting
• Start date: December 10, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: April 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Carlo Ronsini, MD
• Phone: +393277334102
• Email: carlo.ronsini90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Inflammatory Response

Intervention

Diagnostic Test:
• Venous blood sample
Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.

Other:
• Surgical staging of endometrial cancer
Endometrial, adnexal, and lymphoid tissue samples.

Locations

Country	Name	City	State
Italy	Università degli Studi della Campania Luigi Vanvitelli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grading	Anatomic pathology report of cell anaplasia in the sampled tumor	30 days after surgery
Primary	Staging	Anatomic pathology report of extent to which the cancer has spread	30 days after surgery
Primary	Histotype	Anatomic pathology report of tissue types that arise during the growth of cancer	30 days after surgery
Primary	Lymphovascular space invasion	Prognostic factor for recurrence and survival in endometrial cancer	30 days after surgery
Primary	Molecular profile	Biomarker testing of genes and/or proteins	30 days after surgery