Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
-
- STATUS
- Recruiting
-
- participants needed
- 100
-
- sponsor
- National Cancer Institute, Naples
Summary
Approximately one fourth of cases of
The worldwide experience and data on
Some systematic reviews have been published in the last decade, trying to summarize the
literature data. Therapeutic results seem to be promising with a regression rate of
approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of
deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30%
pregnancy rate in patients attempting to conceive, and an overall low rate of assisted
Description
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
PROJECT DESIGN Observational model: Cohort
TIME PERSPECTIVE Prospective
ENDPOINT CLASSIFICATION
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 NationalCancer 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
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
- go to http://www.usc-intnapoli.net;
- select language;
- click "Ask for authorization" to create your personal account;
- fill and send the "authorization form";
- make a screenshot of the "authorization form" and send it to l.sparavigna@istitutotumori.na.it;
- enter into to the system using your credentials and click on "E.C.Co.";
- click "the join request form";
- wait for authorization (a verification message will be sent to your email address within 24-48 h);
- enter into to the system using your credentials and click on "E.C.Co." for patient registration and/or updating.
Details
| Condition |
Endometrial Carcinoma, Uterine |
|---|---|
| Age | 18years - 45years |
| Treatment | data collection |
| Clinical Study Identifier | NCT04290299 |
| Sponsor | National |
| Last Modified on | 19 February 2024 |
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Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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