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NCT Number: NCT05673252

CERvical Cancer The InFlammatory Index (CERTIFIKO)

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous blood sample

Diagnostic Test

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

Biopsy

Procedure

histopathology findings

Primary outcomes

  1. Grading

    Time frame: 30 days after surgery

    Anatomic pathology report of cell anaplasia in the sampled tumor

  2. Staging

    Time frame: 30 days after surgery

    Anatomic pathology report of extent to which the cancer has spread

  3. Lymphovascular space invasion

    Time frame: 30 days after surgery

    Prognostic factor in cervical cancer

  4. Histotype

    Time frame: 30 days after surgery

    Anatomic pathology report of tissue types of cancer

  5. Tumor size

    Time frame: 30 days after surgery

    centimeters

  6. Neutrophil-Lymphocyte Ratio (NLR)

    Time frame: 1 day previous surgery

    an absolute value obtained from the ratio of neutrophils to lymphocytes

  7. Platelet-lymphocyte ratio(PLR)

    Time frame: 1 day previous surgery

    an absolute value obtained from the ratio of platelets to lymphocytes

  8. Lymphocyte-monocyte Ratio (LMR)

    Time frame: 1 day previous surgery

    an absolute value obtained from the ratio of lymphocytes to monocytes

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Acronym: CERTIFIKO

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 6, 2023
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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