CERvical Cancer The InFlammatory Index (CERTIFIKO)

Cervical Cancer Clinical Trial

— CERTIFIKO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673252
• Other study ID #: 0035558/i
• Status: Recruiting
• Start date: November 18, 2022
• Est. completion date: November 18, 2024

Study information

• Verified date: April 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Carlo Ronsini, MD
• Phone: +393277334102
• Email: carlo.ronsini90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 18, 2024
• Est. primary completion date: November 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Venous blood sample
Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts

Procedure:
• biopsy
histopathology findings

Locations

Country	Name	City	State
Italy	Università degli Studi della Campania Luigi Vanvitelli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

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