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CERvical Cancer The InFlammatory Index (CERTIFIKO)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05673252
Acronym
CERTIFIKO
Enrollment
128
Registered
2023-01-06
Start date
2022-11-18
Completion date
2024-11-18
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cervical cancer, neutrophil to lymphocyte ratio (NLR), lymphocyte to monocyte ratio (LMR), platelet to lymphocyte ratio (PLR)

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.

Interventions

DIAGNOSTIC_TESTVenous blood sample

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

PROCEDUREbiopsy

histopathology findings

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grading30 days after surgeryAnatomic pathology report of cell anaplasia in the sampled tumor
Staging30 days after surgeryAnatomic pathology report of extent to which the cancer has spread
Lymphovascular space invasion30 days after surgeryPrognostic factor in cervical cancer
Histotype30 days after surgeryAnatomic pathology report of tissue types of cancer
Tumor size30 days after surgerycentimeters
Neutrophil-Lymphocyte Ratio (NLR)1 day previous surgeryan absolute value obtained from the ratio of neutrophils to lymphocytes
Platelet-lymphocyte ratio(PLR)1 day previous surgeryan absolute value obtained from the ratio of platelets to lymphocytes
Lymphocyte-monocyte Ratio (LMR)1 day previous surgeryan absolute value obtained from the ratio of lymphocytes to monocytes

Countries

Italy

Contacts

Primary ContactCarlo Ronsini, MD
carlo.ronsini90@gmail.com+393277334102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026