Clinical trial NCT05673252: CERvical Cancer The InFlammatory Index (CERTIFIKO)
Official title: CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: Cervical cancer
neutrophil to lymphocyte ratio (NLR)
lymphocyte to monocyte ratio (LMR)
platelet to lymphocyte ratio (PLR)
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-01-06
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 cervical cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.

Brief summary: Although significant advances in screening and treatment , cervical cancer is the fifth most common female cancer in Europe. Major prognostic factors for oncological outcome are used to categorise patients at high, intermediate and low risk groups and to define the type of radical hysterectomy according "Querleu-Morrow classification". The goal of this prospective observational study is to evaluate the association between several inflammatory markers and risk groups according European guidelines in women with cervical cancer Human Papillomavirus (HPV)-associated, in order to optimize the treatment.

Detailed description: European guidelines have proposed a risk stratification of patients basing on oncological risk. The type of radical hysterectomy (extent of parametrial resection and type according Querleu-Morrow classification) should be based upon the presence of prognostic risk factors.Major prognostic factors for oncological outcome as tumour size, maximum stromal invasion, Lymphovascular space invasion (LVSI) are used to categorise patients at high, intermediate and low risk for treatment failure. 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 solid tumors and several inflammatory conditions. Therefore, the primary endpoint of the present study is to assess the role of systemic inflammatory indices and risk groups stratification in patients with early cervical cancer.

Eligibility criteria: Inclusion Criteria:

* At least 18-year-old patients.
* Patients histologically diagnosed with cervical cancer (squamous cell carcinoma or adenocarcinoma HPV- associated)
* Patients with (2018 FIGO) stage ≤ IB2 ("Early Cervical Cancer")
* Patients undergoing full-body CT-scan 30 days before enrollment.

Exclusion Criteria:

* Patients 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: Lymphovascular space invasion
timeFrame: 30 days after surgery
measure: Histotype
timeFrame: 30 days after surgery
measure: Tumor size
timeFrame: 30 days after surgery
measure: Neutrophil-Lymphocyte Ratio (NLR)
timeFrame: 1 day previous surgery
measure: Platelet-lymphocyte ratio(PLR)
timeFrame: 1 day previous surgery
measure: Lymphocyte-monocyte Ratio (LMR)
timeFrame: 1 day previous 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: