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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05657483
Enrollment
128
Registered
2022-12-20
Start date
2022-12-10
Completion date
2024-12-10
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms, Inflammatory Response

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.

Interventions

DIAGNOSTIC_TESTVenous blood sample

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

OTHERSurgical staging of endometrial cancer

Endometrial, adnexal, and lymphoid tissue samples.

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grading30 days after surgeryAnatomic pathology report of cell anaplasia in the sampled tumor
Staging30 days after surgeryAnatomic pathology report of extent to which the cancer has spread
Histotype30 days after surgeryAnatomic pathology report of tissue types that arise during the growth of cancer
Lymphovascular space invasion30 days after surgeryPrognostic factor for recurrence and survival in endometrial cancer
Molecular profile30 days after surgeryBiomarker testing of genes and/or proteins

Countries

Italy

Contacts

Primary ContactCarlo Ronsini, MD
carlo.ronsini90@gmail.com+393277334102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026