CERvical Cancer The InFlammatory Index (CERTIFIKO)

Trial Title: CERvical Cancer The InFlammatory Index (CERTIFIKO)

NCT ID: NCT05673252

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
Cervical cancer
neutrophil to lymphocyte ratio (NLR)
lymphocyte to monocyte ratio (LMR)
platelet to lymphocyte ratio (PLR)

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Venous blood sample
Description: Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts
Arm group label: Cervical cancer patients

Intervention type: Procedure
Intervention name: biopsy
Description: histopathology findings
Arm group label: Cervical cancer patients

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.

Criteria for eligibility:

Study pop:
Patients with histological diagnosis of cervical cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Università degli Studi della Campania Luigi Vanvitelli

Address:
City: Naples
Zip: 80138
Country: Italy

Status: Recruiting

Contact:
Last name: Carlo Ronsini, MD

Phone: 3277334102
Email: carlo.ronsini@unicampania.it

Start date: November 18, 2022

Completion date: November 18, 2024

Lead sponsor:
Agency: University of Campania "Luigi Vanvitelli"
Agency class: Other

Source: University of Campania "Luigi Vanvitelli"

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05673252