Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

PURPOSE The goal of this research project is to learn more about the safety of conservatively treating EC and about subsequent fertility outcome.

PROJECT TYPE Observational (patient archive) - The project runs within the framework of Gynecologic Cancer InterGroup (GCIG), thus, participating Centres must belong to one of the qualified National groups.

PROJECT DESIGN Observational model: Cohort

TIME PERSPECTIVE Prospective

ENDPOINT CLASSIFICATION Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes

INTERVENTIONS Data collection

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

REQUIREMENTS FOR PATIENT REGISTRATION

• 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 (please note that such protocols should be shared with the database owner National Cancer Institute of Naples).

TREATMENT Since 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).

DURATION A first phase of three years is planned, eventually followed by further three years.

PUBLICATION POLICY Data generated are property of all investigators and will be object of publication after general agreement.

DATA TO BE COLLECTED

Patient enrollment and registration of data are made by appropriate eCRFs via the Clinical Trials Unit of National Cancer Institute of Naples (Study Data Center) website through the following steps:

1. go to http://www.usc-intnapoli.net;

2. select language;

3. click "Ask for authorization" to create your personal account;

4. fill and send the "authorization form";

5. make a screenshot of the "authorization form" and send it to l.sparavigna@istitutotumori.na.it;

6. enter into to the system using your credentials and click on "E.C.Co.";

7. click "the join request form";

8. wait for authorization (a verification message will be sent to your email address within 24-48 h);

9. enter into to the system using your credentials and click on "E.C.Co." for patient registration and/or updating.