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Trial Title:
Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
NCT ID:
NCT05657483
Condition:
Endometrial Neoplasms
Inflammatory Response
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Venous blood sample
Description:
Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.
Arm group label:
Endometrial cancer patients
Other name:
Blood chemistry test
Intervention type:
Other
Intervention name:
Surgical staging of endometrial cancer
Description:
Endometrial, adnexal, and lymphoid tissue samples.
Arm group label:
Endometrial cancer patients
Other name:
Biopsy
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.
Criteria for eligibility:
Study pop:
Patients with histological diagnosis of endometrial cancer undergoing surgical
intervention who performed full-body CT-scan 30 days before enrollment.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Università degli Studi della Campania Luigi Vanvitelli
Address:
City:
Naples
Zip:
80138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Ronsini, MD
Phone:
3277334102
Email:
carlo.ronsini@unicampania.it
Start date:
December 10, 2022
Completion date:
December 10, 2024
Lead sponsor:
Agency:
University of Campania "Luigi Vanvitelli"
Agency class:
Other
Source:
University of Campania "Luigi Vanvitelli"
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05657483
