Trials / Recruiting
RecruitingNCT05673252
CERvical Cancer The InFlammatory Index (CERTIFIKO)
CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 128 (estimated)
- Sponsor
- University of Campania Luigi Vanvitelli · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Venous blood sample | Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts |
| PROCEDURE | biopsy | histopathology findings |
Timeline
- Start date
- 2022-11-18
- Primary completion
- 2024-11-18
- Completion
- 2024-11-18
- First posted
- 2023-01-06
- Last updated
- 2024-04-17
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05673252. Inclusion in this directory is not an endorsement.