E.C.Co. E ndometrial C ancer Co nservative treatment A multicentre - PowerPoint PPT Presentation

16 TH BIENNIAL MEETING OF THE INTERNATIONAL GYNECOLOGIC CANCER SOCIETY E.C.Co. E ndometrial C ancer Co nservative treatment A multicentre archive Data collection is made by appropriate eCRFs via the Clinical Trials Unit of National Cancer Institute of Naples (Study Data Center) website s.greggi@istitutotumori.na.it; ginecologia@istitutotumori.na.it

E.C.Co. E ndometrial C ancer Co nservative treatment A multicentre archive P ROJECT T YPE / D ESIGN & T IME P ERSPECTIVE Observational / Patient archive, Prospective (a first phase of three years is planned, eventually followed by further three years) I NCLUSION C RITERIA - Conservatively treated endometrial cancer - Informed consent to personal data processing - Existence of an IRB-approved local protocol that allows conservative treatment to be performed (or statement that such treatment is considered as a standard) I NTERVENTIONS & O UTCOME M EASURES Data collection - P RIMARY O UTCOME M EASURES : proportion of complete regression, duration of response, frequency and pattern of relapse, frequency of metachronous ovarian cancer, tumor-related deaths; S ECONDARY O UTCOME M EASURES : treatment related morbidity, frequency of spontaneous pregnancies, frequency of pregnancies after ART, pattern of residual disease on definitive surgical specimens T REATMENT S INCE THIS IS A ARCHIVE , TREATMENT IS NOT DICTATED BY A PROTOCOL , HOWEVER , TREATMENT HAS TO BE ADMINISTERED ACCORDING TO A IRB- APPROVED LOCAL PROTOCOL (except for the countries where conservative treatment can be given outside a IRB-approved study because considered as a standard procedure)

E.C.Co. E ndometrial C ancer Co nservative treatment A multicentre archive Participation (15/10/2016) Center Code PI Registration date N° of patients registered National Cancer Institute of Naples, 640 Stefano Greggi March 2014 28 Naples. Italy Catholic University of the Sacred 145 Giovanni Scambia September 2015 10 Heart, Rome. Italy Papa Giovanni XXIII Hospital, 254 Chiara Malandrino December 2015 6 Bergamo. Italy San Raffaele Hospital, Milan. Italy 321 Patrizia De Marzi October 2015 - National Cancer Institute of Rome, 741 - July 2016 - Rome. Italy University of Bari, Bari. Italy 111 Gennaro Cormio October 2015 - Women’s The Royal Hospital, 668 - August 2015 - Parkville. Australia The Obstetrics & Gynecology Hospital 676 - September 2015 - of Fudan University, Shanghai. China Leiden Medical University, Leiden. 704 - September 2015 - Netherlands Tot N 44