With Regional Ethics Committee approval, a total of 1046 consenting patients in the MoMaTEC1 trial (Clinical Trial identifier NCT00598845) were included in this study. The study has acquired approval of The Norwegian Data Inspectorate (961478–2), Norwegian Social Sciences Data services (15501), and Regional Committees for Medical and Health Research Ethics (REKIII no. 052.01). A total of 402 endometrial cancer patients were prospectively included when treated at the Department of Gynaecology and Obstetrics, Haukeland University Hospital, Bergen, Norway, from May 2001 to March 2011. Nine other centres contributed with 644 patients treated for endometrial carcinoma prospectively included at their institutions. Sampling was performed by pipelle or dilatation and curettage as per routine for each contributing centre. Formalin-fixed, paraffin-embedded tumour tissue from curettage specimens was collected from all participating institutions.
Clinicopathological data, including age at diagnosis, FIGO stage according to 2009 criteria, histology (type and grade) from hysterectomy specimens, and treatment modalities were recorded. Preoperative curettage histology reports were routinely categorised as either high risk (standardly comprising histological type reported as non-endometrioid, or histological grade 3 endometrioid carcinoma) or low risk (standardly comprising other histological diagnoses including grade 1 or 2 endometrioid carcinoma, hyperplasia, and benign endometrium). All precision samples selected for DNA ploidy analysis as later described were investigated for presence of malignant tissue by one of the co-authors (MP), irrespective of the preoperative routine histological diagnosis. Complying with the aim to evaluate DNA ploidy impact in a patient group treated routinely in a prospective multicentre setting, routine histological reports for grading and subtyping were applied from the participating centres. Follow-up data with records of recurrence and survival were collected from patient records and correspondence with physicians responsible for outpatient controls.
Clinicopathological data, including age at diagnosis, FIGO stage according to 2009 criteria, histology (type and grade) from hysterectomy specimens, and treatment modalities were recorded. Preoperative curettage histology reports were routinely categorised as either high risk (standardly comprising histological type reported as non-endometrioid, or histological grade 3 endometrioid carcinoma) or low risk (standardly comprising other histological diagnoses including grade 1 or 2 endometrioid carcinoma, hyperplasia, and benign endometrium). All precision samples selected for DNA ploidy analysis as later described were investigated for presence of malignant tissue by one of the co-authors (MP), irrespective of the preoperative routine histological diagnosis. Complying with the aim to evaluate DNA ploidy impact in a patient group treated routinely in a prospective multicentre setting, routine histological reports for grading and subtyping were applied from the participating centres. Follow-up data with records of recurrence and survival were collected from patient records and correspondence with physicians responsible for outpatient controls.
