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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03570866
Other study ID # ENCA-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date May 1, 2024

Study information

Verified date September 2021
Source Università degli Studi dell'Insubria
Contact Antonio Simone Laganà, M.D.
Phone ?+39 329 6279579?
Email antoniosimone.lagana@asst-settelaghi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion > 50% or grade 3 endometrioid lesion with < 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion > 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date May 1, 2024
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Women with diagnosis of early stage intermediate and high-risk endometrial cancer. Exclusion Criteria: - Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Positron emission tomography and computed tomography
Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.
Procedure:
Surgical treatment
Surgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria Universita di Verona

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of positron emission tomography and computed tomography Comparing Positron emission tomography and computed tomography results with Histopathological findings served as the standard of reference. True positive, True negative, False positive, False negative. Sensitivity, Specificity, Negative predictive value, Positive predictive value. Through study completion, an average of 5 year
Secondary Progression free survival Events of disease recurrence in the study group Through study completion, an average of 5 year
Secondary Overall survival Events of death in the study group Through study completion, an average of 5 year
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