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CERvical Cancer The InFlammatory Index (CERTIFIKO)

CERvical Cancer The InFlammatory Index (CERTIFIKO)

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

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

Study details
    Cervical Cancer

NCT05673252

University of Campania "Luigi Vanvitelli"

30 April 2024

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