CERvical Cancer The InFlammatory Index (CERTIFIKO) (CERTIFIKO)

August 6, 2026 updated by: Carlo Ronsini, University of Campania Luigi Vanvitelli

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

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Naples
      • Naples, Naples, Italy, 80138
        • Università degli Studi della Campania Luigi Vanvitelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 30 days after surgery
Anatomic pathology report of cell anaplasia in the sampled tumor
30 days after surgery
Staging
Time Frame: 30 days after surgery
Anatomic pathology report of extent to which the cancer has spread
30 days after surgery
Lymphovascular space invasion
Time Frame: 30 days after surgery
Prognostic factor in cervical cancer
30 days after surgery
Histotype
Time Frame: 30 days after surgery
Anatomic pathology report of tissue types of cancer
30 days after surgery
Tumor size
Time Frame: 30 days after surgery
centimeters
30 days after surgery
Neutrophil-Lymphocyte Ratio (NLR)
Time Frame: 1 day previous surgery
an absolute value obtained from the ratio of neutrophils to lymphocytes
1 day previous surgery
Platelet-lymphocyte ratio(PLR)
Time Frame: 1 day previous surgery
an absolute value obtained from the ratio of platelets to lymphocytes
1 day previous surgery
Lymphocyte-monocyte Ratio (LMR)
Time Frame: 1 day previous surgery
an absolute value obtained from the ratio of lymphocytes to monocytes
1 day previous surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Actual)

December 18, 2025

Study Completion (Estimated)

November 18, 2027

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)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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