CERvical Cancer The InFlammatory Index (CERTIFIKO)

NCT ID: NCT05673252

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2024-11-18

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.

Conditions

Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cervical cancer patients

The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer.

Venous blood sample

Intervention Type: DIAGNOSTIC_TEST

Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts

biopsy

Intervention Type: PROCEDURE

histopathology findings

Interventions

Venous blood sample

Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts

Intervention Type: DIAGNOSTIC_TEST

biopsy

histopathology findings

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Carlo Ronsini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Ronsini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Università degli Studi della Campania Luigi Vanvitelli

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Ronsini, MD

Role: CONTACT

carlo.ronsini90@gmail.com

+393277334102

Facility Contacts

Carlo Ronsini, MD

Role: primary

carlo.ronsini@unicampania.it

3277334102

Other Identifiers

0035558/i

Identifier Type: -

Identifier Source: org_study_id