Odal METastasis in high risk Endometrial Cancer (NOMETEC): detection methods and the prevalence of lymph node micrometastasis
- Conditions
- (high risk) endometrial cancer10038594
- Registration Number
- NL-OMON39933
- Lead Sponsor
- Diakonessenhuis Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 290
This study is a multicenter cross-sectional diagnostic invention study, consisting of two sub-studies. ;Inclusion criteria PART I:
====================;All women, undergoing a hysteroscopic curettage and a hysterectomy because of suspicion for a (malignant) lesion of the endometrium.;Inclusion criteria PART II:
====================;Only patients with high risk endometrial cancer will be included in this study, because - according to the recently revised national guideline - standard care in these patients includes a pelvic and para-aortal lymphadenctomy. High risk patients are defined as having at least one of the following characteristics: differentiation grade 3, > 50% myometrial invasion, suspicious for extra-corporal spread, high risk histological type (serous papillary, clear cell or carcinosarcoma tumour type)
Exclusion criteria PART I and PART II:
==============================;Patients with contraindications for open abdominal or laparoscopic surgery will be excluded: cervical or pelvic infection, severe cardio-pulmonal or other co-morbidity contra-indicating extensive surgery and anaesthesia.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome parameter PART I<br /><br>============================<br /><br><br /><br>Both techniques will be compared for:<br /><br>- sentinel node detection rate (min. 80% DR)<br /><br>- the location and level of the sentinel nodes (pelvic and/or para-aortal, high<br /><br>and/or low)<br /><br>- patient friendliness (questionnaire)<br /><br>- doctor friendliness (questionnaire)<br /><br><br /><br><br /><br>Primary outcome parameter PART II<br /><br>============================<br /><br><br /><br>The reliability of the sentinel node procedure in high risk endometrial cancer,<br /><br>which will be determined by the false negative rate after histological<br /><br>examination of all removed nodes using the *gold standard* (= multiple<br /><br>sectioning Hematoxylin and Eosin (H&E) staining and immunohistochemistry (IHC)) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters PART II:<br /><br>================================<br /><br><br /><br>1) The prevalence location of lymphnode metastasis (pelvic and/o high/low<br /><br>para-aortal).<br /><br>2) The prevalence of lymphnode micrometastasis in high risk endometrial cancer.<br /><br>3) The feasibility and reliability of the OSNA CK19 test as an intraoperative<br /><br>method to diagnose lymph node macro- and micrometastasis in sentinel nodes will<br /><br>be tested. Histopathological examination (H&E) will be used as control method.<br /><br>In case of discordant cases immunohistochemistry will be used as reference<br /><br>method. The reliability will be defined by the true histological false negative<br /><br>rate. </p><br>