|- candidate number||13095|
|- NTR Number||NTR3503|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jul-2012|
|- Secondary IDs||1129 METC St. Elisabeth Hospital, Tilburg|
|- Public Title||Recognition of risk factors for extended disease and relapse in endometrial carcinoma biopsies, an observational study.|
|- Scientific Title||Recognition of risk factors for extended disease and relapse in endometrial carcinoma biopsies, an observational study.|
|- hypothesis||Standardize evaluation of endometrial biopsies, with additional immunohistochemical analysis can predict final pathology (i.e. papillary serous or clear cell histology), myometrial invasion and lymph node involvement.|
|- Healt Condition(s) or Problem(s) studied||Postmenopausal bleeding, Endometrial carcinoma, Endometrial biopsy|
|- Inclusion criteria||Patients with a primary endometrial carcinoma being considerd for operation.|
|- Exclusion criteria||1. No pre-operative histology;|
2. Benign pre-operative histology;
3. No operation because of co-morbidity / wish patient;
4. History of hysterectomy and/or endometrial carcinoma.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||300|
|- Interventions||Immunohistochemical analysis of IGF, p53, ER, hMLH1, PTEN, Her2-neu, LVSI and L1-cam.|
|- Primary outcome||1. Final pathology;|
2. Myometrial invasion;
3. Lymph node involement.
|- Secondary outcome||1. Extended disease;|
3. Disease free survival.
|- Timepoints||Follow-up 24 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. N.C.M. Visser|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. J.M.A. Pijnenborg|
|- Sponsor/Initiator ||TweeSteden hospital, location Tilburg|
(Source(s) of Monetary or Material Support)
|TweeSteden hospital, location Tilburg|
|- Brief summary||Introduction and rationale:|
Endometrial carcinoma is the most common gynecologic malignancy in the Western World. Final histology in high grade lesions is frequently not corresponding with the preoperative diagnosis. The clinical problem of endometrial carcinoma patients is characterized by the difficulties of a properly early recognition of patients high grade and serous/clear cell histology as well as extended disease preoperatively, in order to select those patients that would potentially benefit from extended surgery and/or additional treatment.
To determine whether standardized evaluation of endometrial biopsies, with additional immunohistochemical analysis could predict final pathology: i.e. papillary serous or clear cell histology, myometrial invasion, and lymph node involvement.
To determine whether additional immunohistochemical analysis on endometrial biopsies with serum tumor markers could contribute into the pre-operative selection of patients at risk for extended disease. To determine whether immunohistochemical analysis, and comorbidity could predict recurrence and disease free survival.
Observational multicenter study. From September 1th 2011 till September 2013 all patients treated for endometrial cancer within one of the participating hospitals within the Comprehensive Cancer Center South (CCCS)and the Canisius Wilhelmina Hospital, Nijmegen, the Netherlands will be included. Patient characteristics, as well as co morbidity, BMI, family history of hereditary syndromes, postmenopausal status and parity are registered. Treatment, and final pathology are registered as well as follow-up and the occurrence of recurrent disease. The endometrial biopsy or curettage in which the diagnosis of endometrial cancer was made will be used for systematic evaluation by one pathologist with special interest in gynecologic oncology. Moreover, additional immunohistochemical analysis of will be performed. Final pathology will be reviewed by one of the experts pathologists within the CCS and compared with the pre-operative histological diagnosis.
|- Main changes (audit trail)|
|- RECORD||3-jul-2012 - 13-jul-2012|