Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 01/31/2020 |
| Enviado pela primeira vez: | 02/26/2020 |
| Inscrição estimada enviada: | 02/26/2020 |
| Postado pela primeira vez: | 02/27/2020 |
| Última atualização enviada: | 05/12/2020 |
| Última atualização postada: | 05/14/2020 |
| Data real de início do estudo: | 09/14/2015 |
| Data Estimada de Conclusão Primária: | 01/31/2025 |
| Data Estimada de Conclusão do Estudo: | 04/07/2025 |
Condição ou doença
Intervenção / tratamento
Other: Data collection
Fase
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | Female |
| Método de amostragem | Non-Probability Sample |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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: - |
Resultado
Medidas de Resultado Primário
1. Proportion of complete regression [10 years]
2. Duration of response [10 years]
3. Frequency of relapse [10 years]
4. Pattern of relapse [10 years]
5. Frequency of metachronous ovarian cancer [10 years]
6. Tumor-related deaths [10 years]
Medidas de Resultado Secundário
1. Treatment related morbidity [10 years]
2. Frequency of spontaneous pregnancies [10 years]
3. Frequency of pregnancies after ART [10 years]
4. Frequency of residual disease on definitive surgical specimens [10 years]
