Endometrial NeoplasmsNCT05657483
Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
An observational study of Endometrial Neoplasms and Inflammatory Response, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, Inflammatory Response
- What is being tested?
- Venous blood sample and Surgical staging of endometrial cancer
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2022to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 endometrial cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.
Who may be able to join
- Patients histologically diagnosed with endometrial cancer.
- Patients undergoing surgical staging of the disease.
- Patients undergoing full-body CT-scan 30 days before enrollment.
- At least 18-year-old patients.
Who cannot join
- 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, 1 recruiting
- Recruiting
Università degli Studi della Campania Luigi Vanvitelli
Naples, 80138
Carlo Ronsini, MD, 3277334102, carlo.ronsini@unicampania.it
About this study
It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.
The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.
Read the detailed description
Surgical treatment for endometrial cancer is class A radical hysterectomy according to Querleu-Morrow and bilateral adnexectomy with systematic pelvic lymphadenectomy. That allows the choice of adjuvant treatment, basing on anatomopathological risk information. Despite the standardization of adjuvant treatments, survival curves are heterogeneous in patients' responses. That is why European guide-lines have proposed a stratification of patients basing on oncological risk and molecular data (Microsatellite instability, aberrant P53, POLE gene mutation). 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 several inflammatory conditions and solid tumors. Therefore, the Investigators have decided to explore their role also in recently diagnosed endometrial cancers, to find correlations with lymphovascular space invasion (LVSI), myometrial infiltration, histotype, and therefore with oncological risk classification. It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.
The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.
- Conditions
- Endometrial Neoplasms, Inflammatory Response
- Being tested
- Venous blood sample, Surgical staging of endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampleDiagnostic test
Also called Blood chemistry test
Blood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts.
Surgical staging of endometrial cancerOther
Also called Biopsy
Endometrial, adnexal, and lymphoid tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer patients | At least 18-year-old patients histologically diagnosed with endometrial cancer who will undergo surgical staging of disease after performing full-body CT-scan 30 days before the enrollment. Receives: Diagnostic Test: Venous blood sample; Other: Surgical staging of endometrial cancer |
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
Histotype
Anatomic pathology report of tissue types that arise during the growth of cancer
Measured: 30 days after surgery
Lymphovascular space invasion
Prognostic factor for recurrence and survival in endometrial cancer
Measured: 30 days after surgery
Molecular profile
Biomarker testing of genes and/or proteins
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start10 Dec 2022
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2024 (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 Endometrial NeoplasmsStudies 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
- NCT05657483
- Sponsor's protocol ID
- 0035563/i
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ronsini C, Iavarone I, Vastarella MG, Della Corte L, Andreoli G, Bifulco G, Cobellis L, de Franciscis P. Additional Risk Factors Lead to a Measurable Inflammatory Response in Stage I Endometrial Cancer-A Prospective Multicentric Observational Study. Indian J Surg Oncol. 2025 Dec;16(6):1474-1481. doi: 10.1007/s13193-025-02228-5. Epub 2025 Feb 24.
PubMed 41415794
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study
- ClinicalTrials.gov ID
- NCT05657483
- Acronym / sponsor ID
- 0035563/i
- Conditions
- Endometrial Neoplasms, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 20 Dec 2022 (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.
It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.
The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.
Detailed description
Surgical treatment for endometrial cancer is class A radical hysterectomy according to Querleu-Morrow and bilateral adnexectomy with systematic pelvic lymphadenectomy. That allows the choice of adjuvant treatment, basing on anatomopathological risk information. Despite the standardization of adjuvant treatments, survival curves are heterogeneous in patients' responses. That is why European guide-lines have proposed a stratification of patients basing on oncological risk and molecular data (Microsatellite instability, aberrant P53, POLE gene mutation). 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 several inflammatory conditions and solid tumors. Therefore, the Investigators have decided to explore their role also in recently diagnosed endometrial cancers, to find correlations with lymphovascular space invasion (LVSI), myometrial infiltration, histotype, and therefore with oncological risk classification. It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.
The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer patients | – | Diagnostic Test: Venous blood sample, Other: Surgical staging of endometrial cancerAt least 18-year-old patients histologically diagnosed with endometrial cancer who will undergo surgical staging of disease after performing full-body CT-scan 30 days before the enrollment. |
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 endometrial cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.
Key inclusion criteria (4 listed)
- Patients histologically diagnosed with endometrial cancer.
- Patients undergoing surgical staging of the disease.
- Patients undergoing full-body CT-scan 30 days before enrollment.
- At least 18-year-old patients.
Key exclusion criteria (4 listed)
- 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 sampleAlso: Blood chemistry testBlood chemistry tests: neutrophil; lymphocyte; monocyte; platelet counts. | Diagnostic test | Endometrial cancer patients |
| Surgical staging of endometrial cancerAlso: BiopsyEndometrial, adnexal, and lymphoid tissue samples. | Other | Endometrial 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
Histotype
Time frame: 30 days after surgery
Anatomic pathology report of tissue types that arise during the growth of cancer
Lymphovascular space invasion
Time frame: 30 days after surgery
Prognostic factor for recurrence and survival in endometrial cancer
Molecular profile
Time frame: 30 days after surgery
Biomarker testing of genes and/or proteins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 41415794Ronsini C, Iavarone I, Vastarella MG, Della Corte L, Andreoli G, Bifulco G, Cobellis L, de Franciscis P. Additional Risk Factors Lead to a Measurable Inflammatory Response in Stage I Endometrial Cancer-A Prospective Multicentric Observational Study. Indian J Surg Oncol. 2025 Dec;16(6):1474-1481. doi: 10.1007/s13193-025-02228-5. Epub 2025 Feb 24.
- Individual participant dataSharing planned: Yes
Related trials for Endometrial Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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 Endometrial Neoplasms and Inflammatory Response, 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Ronsini, MD (+393277334102, carlo.ronsini90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading (time frame: 30 days after surgery). The study lists 5 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 NCT05657483, 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 17 Apr 2024.