Evaluating inflammatory markers in early cervical cancer
CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
This study is trying to see if certain inflammation markers can help doctors better understand the risk levels in women with early cervical cancer linked to HPV, so they can tailor treatments more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05673252 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between various inflammatory markers and risk stratification in women diagnosed with early cervical cancer associated with Human Papillomavirus (HPV). By analyzing systemic inflammation indices such as the neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio (LMR), the study seeks to enhance the current European guidelines for categorizing patients into high, intermediate, and low-risk groups. The ultimate goal is to optimize treatment strategies based on these risk profiles, which are determined by established prognostic factors and additional inflammatory parameters.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with a histological diagnosis of HPV-associated cervical cancer at FIGO stage ≤ IB2.
Not a fit: Patients with chronic inflammatory diseases, synchronous tumors, or those undergoing recent steroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with early cervical cancer.
How similar studies have performed: While the use of inflammatory markers in cancer prognosis is established, this specific approach to cervical cancer risk stratification is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Naples
- Università degli Studi della Campania Luigi Vanvitelli — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Ronsini, MD — University of Campania Luigi Vanvitelli
- Study coordinator: Carlo Ronsini, MD
- Email: carlo.ronsini90@gmail.com
- Phone: +393277334102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.