Clinical trial NCT03570866: PET/CT in the Management of Patients With Early Stage Endometrial Cancer
Official title: Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrium Cancer
Keywords: Endometrial cancer
Positron emission tomography
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2018-06-27
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman referred for diagnosis of early stage intermediate and high-risk endometrial cancer that undergo PET/CT staging and standard surgical treatment.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of positron emission tomography and computed tomography
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
measure: Progression free survival
timeFrame: Through study completion, an average of 5 year
measure: Overall survival
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Simone Garzon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Massimo Franchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: