CERvical Cancer The InFlammatory Index (CERTIFIKO)

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT05673252
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Study Timeline

• Study Start: 2022-11-18
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-11-18
• Study Completion: 2024-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 128

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Università degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Naples, Italy