CERvical Cancer The InFlammatory Index (CERTIFIKO)

Study Overview
=================
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.

Official Title
-----------------
CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Venous blood sample
* Procedure: biopsy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical cancer patients<br>The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer. | Diagnostic Test: Venous blood sample<br>* Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts<br>Procedure: biopsy<br>* histopathology findings<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Lymphovascular space invasion | Prognostic factor in cervical cancer | 30 days after surgery | 
| Histotype | Anatomic pathology report of tissue types of cancer | 30 days after surgery | 
| Tumor size | centimeters | 30 days after surgery | 
| Neutrophil-Lymphocyte Ratio (NLR) | an absolute value obtained from the ratio of neutrophils to lymphocytes | 1 day previous surgery | 
| Platelet-lymphocyte ratio(PLR) | an absolute value obtained from the ratio of platelets to lymphocytes | 1 day previous surgery | 
| Lymphocyte-monocyte Ratio (LMR) | an absolute value obtained from the ratio of lymphocytes to monocytes | 1 day previous surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cancer, neutrophil to lymphocyte ratio (NLR), lymphocyte to monocyte ratio (LMR), platelet to lymphocyte ratio (PLR)