JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04290299

Studienbeginn:
September 2015

Letztes Update:
13.10.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Endometrial Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
National Cancer Institute, Naples

Collaborator:
-

Studienleiter

Stefano Greggi, MD
Principal Investigator
National Cancer Institute of Naples

Kontakt

Stefano Greggi, MD
Kontakt:
Phone: +39.081.5903417
E-Mail: s.greggi@istitutotumori.na.it» Kontaktdaten anzeigen

Francesca Falcone, MD
Kontakt:
Phone: +39.081.5903417
E-Mail: francesca.falcone@istitutotumori.na.it» Kontaktdaten anzeigen

Studienlocations
(3 von 19)

AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom
Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

Cooperative Ovarian Cancer Group (COGI)
Stanford
United StatesRekrutierend» Google-Maps

ANZGOG - Australia and New Zealand Gynecological Oncology Group
Sydney
AustraliaRekrutierend» Google-Maps

AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie
Vienna
AustriaRekrutierend» Google-Maps

EORTC - European Organization for Research and Treatment of Cancer
Brussels
BelgiumRekrutierend» Google-Maps

NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
Ottawa
CanadaRekrutierend» Google-Maps

PMHC (Princess Margaret Hospital Consortium)
Toronto
CanadaRekrutierend» Google-Maps

SGOG (Shanghai Gynecologic Oncology Group)
Shangai
ChinaRekrutierend» Google-Maps

NSGO (Nordic Society of Gynecologic Oncology)
Copenhagen
DenmarkRekrutierend» Google-Maps

GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
Paris
FranceRekrutierend» Google-Maps

ICORG - Ireland Cooperative Oncology Research Group
Dublin
IrelandRekrutierend» Google-Maps

MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
Naples
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Stefano Greggi, MD
E-Mail: s.greggi@istitutotumori.na.it» Ansprechpartner anzeigen

GOTIC - Gynecologic Oncology Trial and Investigation Consortium
Katō
JapanRekrutierend» Google-Maps

JGOG - Japanese Gynecologic Oncology Group
Tokyo
JapanRekrutierend» Google-Maps

KGOG - Korean Gynecologic Oncology Group
Seul
Korea, Republic ofRekrutierend» Google-Maps

DGOG - Dutch Gynecologic Oncology Group
Amsterdam
NetherlandsRekrutierend» Google-Maps

GEICO - Grupo Espanol de Investigacion en Cancer de Ovario
Madrid
SpainRekrutierend» Google-Maps

SGCTG (Scottish Gynaecological Cancer Trials Group)
Edinburgh
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed 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

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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).

Exclusion Criteria:

-

Studien-Rationale

Primary outcome:

1. Proportion of complete regression (Time Frame - 10 years)

2. Duration of response (Time Frame - 10 years)

3. Frequency of relapse (Time Frame - 10 years)

4. Pattern of relapse (Time Frame - 10 years)

5. Frequency of metachronous ovarian cancer (Time Frame - 10 years)

6. Tumor-related deaths (Time Frame - 10 years)

Secondary outcome:

1. Treatment related morbidity (Time Frame - 10 years)

2. Frequency of spontaneous pregnancies (Time Frame - 10 years)

3. Frequency of pregnancies after ART (Time Frame - 10 years)

4. Frequency of residual disease on definitive surgical specimens (Time Frame - 10 years)

Geprüfte Regime

Data collection:
Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes

Quelle: ClinicalTrials.gov

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