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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cancer patients | The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sample | Diagnostic Test | Blood chemistry tests: neutrophil;lymphocyte; monocyte; platelet counts |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histological diagnosis of cervical cancer undergoing surgical intervention who performed full-body CT-scan 30 days before enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Ronsini, MD | Contact | +393277334102 | carlo.ronsini90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Ronsini, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli Studi della Campania Luigi Vanvitelli | Recruiting | Naples | 80138 | Italy |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| biopsy | Procedure | histopathology findings |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |