Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
NCT ID: NCT04290299
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-09-15
2025-04-08
Brief Summary
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The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.
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 reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.
Detailed Description
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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 [email protected];
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Data collection
Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Stefano Greggi, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute of Naples
Locations
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Cooperative Ovarian Cancer Group (COGI)
Stanford, California, United States
ANZGOG - Australia and New Zealand Gynecological Oncology Group
Sydney, , Australia
AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie
Vienna, , Austria
EORTC - European Organization for Research and Treatment of Cancer
Brussels, , Belgium
NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
Ottawa, , Canada
PMHC (Princess Margaret Hospital Consortium)
Toronto, , Canada
SGOG (Shanghai Gynecologic Oncology Group)
Shanghai, , China
NSGO (Nordic Society of Gynecologic Oncology)
Copenhagen, , Denmark
GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
Paris, , France
AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom
Berlin, , Germany
NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
Berlin, , Germany
ICORG - Ireland Cooperative Oncology Research Group
Dublin, , Ireland
MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
Naples, , Italy
GOTIC - Gynecologic Oncology Trial and Investigation Consortium
Katō, , Japan
JGOG - Japanese Gynecologic Oncology Group
Tokyo, , Japan
DGOG - Dutch Gynecologic Oncology Group
Amsterdam, , Netherlands
KGOG - Korean Gynecologic Oncology Group
Seoul, , South Korea
GEICO - Grupo Espanol de Investigacion en Cancer de Ovario
Madrid, , Spain
SGCTG (Scottish Gynaecological Cancer Trials Group)
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13/15 oss
Identifier Type: -
Identifier Source: org_study_id