CERvical Cancer The InFlammatory Index (CERTIFIKO)

NCT05673252 | Recruiting

• 1 other identifier: 0035558/i
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Grading

  Anatomic pathology report of cell anaplasia in the sampled tumor

  30 days after surgery

• Staging

  Anatomic pathology report of extent to which the cancer has spread

  30 days after surgery

• Lymphovascular space invasion

  Prognostic factor in cervical cancer

  30 days after surgery

• Histotype

  Anatomic pathology report of tissue types of cancer

  30 days after surgery

• Tumor size

  centimeters

  30 days after surgery

• Neutrophil-Lymphocyte Ratio (NLR)

  an absolute value obtained from the ratio of neutrophils to lymphocytes

  1 day previous surgery

• Platelet-lymphocyte ratio(PLR)

  an absolute value obtained from the ratio of platelets to lymphocytes

  1 day previous surgery

• Lymphocyte-monocyte Ratio (LMR)

  an absolute value obtained from the ratio of lymphocytes to monocytes

  1 day previous surgery

Study Arms (1)

Cervical cancer patients

The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer.

Diagnostic Test: Venous blood sample; Procedure: biopsy

Interventions

Venous blood sample DIAGNOSTIC_TEST

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

Cervical cancer patients

biopsy PROCEDURE

histopathology findings

Cervical cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carlo Ronsini, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Ronsini, MD

CONTACT

+393277334102; [email protected]

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 6, 2023
• Study Start: November 18, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)