NCT05657483

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 10, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

December 1, 2022

Last Update Submit

April 16, 2024

Conditions

Endometrial NeoplasmsInflammatory Response

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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 sampleOther: Surgical staging of endometrial cancer

Interventions

Venous blood sampleDIAGNOSTIC_TEST

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

Also known as: Blood chemistry test
Endometrial cancer patients
Surgical staging of endometrial cancerOTHER

Endometrial, adnexal, and lymphoid tissue samples.

Also known as: Biopsy
Endometrial cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

RECRUITING

Related Publications (1)

  • Ronsini C, Iavarone I, Vastarella MG, Corte LD, Andreoli G, Bifulco G, Cobellis L, de Franciscis P. Additional Risk Factors Lead to a Measurable Inflammatory Response in Stage I Endometrial Cancer-A Prospective Multicentric Observational Study. Indian J Surg Oncol. 2025 Dec;16(6):1474-1481. doi: 10.1007/s13193-025-02228-5. Epub 2025 Feb 24.

    PMID: 41415794DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Carlo Ronsini, MD

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Ronsini, MD

CONTACT

+393277334102carlo.ronsini90@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 20, 2022

Study Start

December 10, 2022

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations

IT(1)