2. Criticisms
Conservative treatment of EC
Limited amount of data
Retrospective studies in most cases
Often short follow-up
Insufficient information on reproductive outcome
Lack of pretreatment fertility counseling
Prospective, multicentre registry study to systematically collect data (oncological and obstetrical outcomes) on consecutive patients treated according to institutionally defined protocols

3. E.C.CO.
Endometrial Cancer - COnservative treatment
A multicentre registry study
Protocol (1)
Purpose
The goal of this research project is to learn more about the safety of conservatively treating EC and about subsequent fertility outcome
Study Type
Observational (patient registry)
Study Design
Observational Model (cohort)
Time Perspective
Prospective
Endpoint Classification
Treatment and outcome registry study
Interventions
Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (hormonal therapy ± surgery), disease and survival outcomes, post-intervention reproductive and obstetric outcomes
Duration of the Study
A first phase of three years is planned, eventually followed by further three years

4. Protocol (2) Outcome Measures Primary Outcome Measures
E.C.CO.
Endometrial Cancer - COnservative treatment
A multicentre registry study
Protocol (2)
Outcome Measures
Primary Outcome Measures
proportion of complete regression
duration of response
frequency and pattern of relapse
frequency of metachronous ovarian cancer
tumor-related deaths
Secondary Outcome Measures
treatment related morbidity
frequency of spontaneous pregnancies
frequency of pregnancies after ART
pattern of residual disease on definitive surgical specimens
Ancillary
patient serum and tumor samples collection (to be stored in situ -20°C) for future research

5. Protocol (3) Eligibility Inclusion Criteria age up to 40 years
E.C.CO.
Endometrial Cancer - COnservative treatment
A multicentre registry study
Protocol (3)
Eligibility
Inclusion Criteria
age up to 40 years
histologically proven EC
strong desire to preserve fertility and complete the follow-up program
oncology and fertility counseling and informed consent
Exclusion Criteria
history of previous/concomitant cancer (except for adequately treated skin basal cell or in situ cervical cancer)
patient belonging to a family with hereditary non-polyposis colorectal cancer (Lynch II syndrome)
synchronous ovarian cancer at magnetic resonance imaging (MRI) or laparoscopy
contraindications for progestin treatment or levonorgestrel-releasing intrauterine system (LNG-IUS) insertion
Treatment
There is not one defined protocol (registry study), but treatment, however, is to be administered according to a IRB-approved protocol (already active protocols in Gynecologic Cancer Intergroup member institutions are incorporated in the study package and recommended)
Pretreatment fertility counseling and patient informed consent are considered mandatory
Pathological criteria are defined for differential diagnosis of endometrial hyperplasia and low grade adenocarcinoma
Definitive surgery should be planned, and pathological data available

6. Data to be collected (1)

7. Data to be collected (2)

8. Data to be collected (3)

9. Work instructions 1) link to https://usc-intnapoli.net/v2-uosc-servizi
The E.C.CO. study, endorsed by GCIG, is open since July 2014 for case registration through the following steps:
Work instructions
1) link to
2) create your personal account (clicking on "Ask for authorization")
3) wait for your credentials (automatically sent to your address within 24-48h)
4) enter into to the system using your credentials and click on "Early Endometrial Cancer" for patient registration and/or updating
For protocol information: or
For website assistance: or
Study Data Center
Clinical Trials Unit
Istituto Nazionale dei Tumori di Napoli “Fondazione G. Pascale” IRCCS, Naples, Italy

10. Participation Invitation Acceptance Registration
AGO-AUST (Arbeitsgemeinschaft Gynaekologische Onkologie Austria)
Marth, Christian
AGO-De (Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany)
Pfisterer, Jacobus
ANZGOG (Australia and New Zealand Gynecological Oncology Group)
Brand, Alison - Quinn, Michael
COGi (Cooperative Ovarian Cancer Group)
Berek, Jonathan
DGOG (Dutch Gynecologic Oncology Group)
Creutzberg, Carien CL
EORTC(European Organization for Research and Treatment of Cancer)
Casado Herráez, Antonio
GEICO (Grupo Espanol de Investigacion en Cancer de Ovario)
Poveda, Andres
GINECO (Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens)
Hardy-Bessard, Anne-Claire - Pujade-Lauraine, Eric ​
GOTIC (Gynecologic Oncology Trial and Investigation Consortium)
Fujiwara, Keiichi
ICORG (Ireland Cooperative Oncology Research Group)
O' Donnell, Dearbhaile
JGOG (Japanese Gynecologic Oncology Group)
Aoki, Daisuke
KGOG (Korean Gynecologic Oncology Group)
Kim, Jae Weon
MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
Greggi, Stefano
NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
Fung-Kee-Fung, Michael - Stuart​, Gavin
NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
Sehouli, Jalid​
NSGO (Nordic Society of Gynecologic Oncology)
Mirza, Mansoor Raza
PMHC (Princess Margaret Hospital Consortium)
Oza, Amit
SGCTG (Scottish Gynaecological Cancer Trials Group)
Siddiqui, Nadeem
SGOG (Shanghai Gynecologic Oncology Group)
Chen, Xiaojun Fudan University, Shanghai, China
For case registration,
MITO sites please contact:
Invitation
Acceptance
Registration