Cervical CancerCERTIFIKONCT05673252
CERvical Cancer The InFlammatory Index (CERTIFIKO)
An observational study of Cervical Cancer, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Venous blood sample and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2023to 18 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histological diagnosis of cervical cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli Studi della Campania Luigi Vanvitelli
Naples, Naples, 80138
About this study
Official title: CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
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.
Read the 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
- Cervical Cancer
- Being tested
- Venous blood sample, biopsy
- Keywords
- Cervical cancer, neutrophil to lymphocyte ratio (NLR), lymphocyte to monocyte ratio (LMR), platelet to lymphocyte ratio (PLR)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampleDiagnostic test
Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts
biopsyProcedure or surgery
histopathology findings
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer patients | The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer. Receives: Diagnostic Test: Venous blood sample; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading
Anatomic pathology report of cell anaplasia in the sampled tumor
Measured: 30 days after surgery
Staging
Anatomic pathology report of extent to which the cancer has spread
Measured: 30 days after surgery
Lymphovascular space invasion
Prognostic factor in cervical cancer
Measured: 30 days after surgery
Histotype
Anatomic pathology report of tissue types of cancer
Measured: 30 days after surgery
Tumor size
centimeters
Measured: 30 days after surgery
Neutrophil-Lymphocyte Ratio (NLR)
an absolute value obtained from the ratio of neutrophils to lymphocytes
Measured: 1 day previous surgery
Platelet-lymphocyte ratio(PLR)
an absolute value obtained from the ratio of platelets to lymphocytes
Measured: 1 day previous surgery
Lymphocyte-monocyte Ratio (LMR)
an absolute value obtained from the ratio of lymphocytes to monocytes
Measured: 1 day previous surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start18 Jul 2023
- Primary completion18 Dec 2025
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Ronsini, University of Campania Luigi Vanvitelli
- Investigators
- Carlo Ronsini, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673252
- Sponsor's protocol ID
- 0035558/i
- Acronym
- CERTIFIKO
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ronsini C, Di Nuzzo A, Solazzo MC, Scaffa C, Ascione C, Chiantera V. Exploratory Analysis of Systemic Inflammatory Indices Across Locoregional Tumor Progression Parameters in Cervical Cancer: The CERTIFIKO Prospective Study. Medicina (Kaunas). 2026 Aug 17;62(8):1570. doi: 10.3390/medicina62081570.
PubMed 42654467
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
- ClinicalTrials.gov ID
- NCT05673252
- Acronym / sponsor ID
- CERTIFIKO / 0035558/i
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, neutrophil to lymphocyte ratio (NLR), lymphocyte to monocyte ratio (LMR), platelet to lymphocyte ratio (PLR)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer patients | – | Diagnostic Test: Venous blood sample, Procedure: biopsyThe population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological diagnosis of cervical cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampleBlood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts | Diagnostic test | Cervical cancer patients |
| biopsyhistopathology findings | Procedure or surgery | Cervical cancer patients |
Primary outcome
Grading
Time frame: 30 days after surgery
Anatomic pathology report of cell anaplasia in the sampled tumor
Staging
Time frame: 30 days after surgery
Anatomic pathology report of extent to which the cancer has spread
Lymphovascular space invasion
Time frame: 30 days after surgery
Prognostic factor in cervical cancer
Histotype
Time frame: 30 days after surgery
Anatomic pathology report of tissue types of cancer
Tumor size
Time frame: 30 days after surgery
centimeters
Neutrophil-Lymphocyte Ratio (NLR)
Time frame: 1 day previous surgery
an absolute value obtained from the ratio of neutrophils to lymphocytes
Platelet-lymphocyte ratio(PLR)
Time frame: 1 day previous surgery
an absolute value obtained from the ratio of platelets to lymphocytes
Lymphocyte-monocyte Ratio (LMR)
Time frame: 1 day previous surgery
an absolute value obtained from the ratio of lymphocytes to monocytes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 42654467Ronsini C, Di Nuzzo A, Solazzo MC, Scaffa C, Ascione C, Chiantera V. Exploratory Analysis of Systemic Inflammatory Indices Across Locoregional Tumor Progression Parameters in Cervical Cancer: The CERTIFIKO Prospective Study. Medicina (Kaunas). 2026 Aug 17;62(8):1570. doi: 10.3390/medicina62081570.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Ronsini, MD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading (time frame: 30 days after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.