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van CCT (UK)

van CCT (UK)

Recognition of risk factors for extended disease and relapse in endometrial carcinoma biopsies, an observational study.

- candidate number13095
- NTR NumberNTR3503
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2012
- Secondary IDs1129 METC St. Elisabeth Hospital, Tilburg
- Public TitleRecognition of risk factors for extended disease and relapse in endometrial carcinoma biopsies, an observational study.
- Scientific TitleRecognition of risk factors for extended disease and relapse in endometrial carcinoma biopsies, an observational study.
- hypothesisStandardize 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) studiedPostmenopausal bleeding, Endometrial carcinoma, Endometrial biopsy
- Inclusion criteriaPatients with a primary endometrial carcinoma being considerd for operation.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate1-sep-2013
- Target number of participants300
- InterventionsImmunohistochemical analysis of IGF, p53, ER, hMLH1, PTEN, Her2-neu, LVSI and L1-cam.
- Primary outcome1. Final pathology;
2. Myometrial invasion;
3. Lymph node involement.
- Secondary outcome1. Extended disease;
2. Recurrence;
3. Disease free survival.
- TimepointsFollow-up 24 months.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator TweeSteden hospital, location Tilburg
- Funding
(Source(s) of Monetary or Material Support)
TweeSteden hospital, location Tilburg
- PublicationsN/A
- Brief summaryIntroduction 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.

Primary objective:
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.
Secondary objectives:
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.

Study design:
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)
- RECORD3-jul-2012 - 13-jul-2012

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