CERvical Cancer The InFlammatory Index (CERTIFIKO) (CERTIFIKO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Diagnostic test: Venous blood sample; Procedure: biopsy

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.

• Study Type: Observational
• Enrollment (Estimated): 128

Contacts and Locations

• Study Contact: Name: Carlo Ronsini, MD; Phone Number: +393277334102; Email: carlo.ronsini90@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80138
    • Recruiting
    • Università degli studi della Campania Luigi Vanvitelli
    • Contact: Carlo Ronsini, MD; Phone Number: 3277334102; Email: carlo.ronsini@unicampania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervical cancer patients; The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer.	Diagnostic test: Venous blood sample; Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts; Procedure: biopsy; histopathology findings

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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Carlo Ronsini, MD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): November 18, 2024
• Study Completion (Estimated): November 18, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cervical cancer; neutrophil to lymphocyte ratio (NLR); lymphocyte to monocyte ratio (LMR); platelet to lymphocyte ratio (PLR)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: 0035558/i

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No