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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical practice in Brazil and Argentina and who meet the eligibility criteria for this study, without additional intervention.
This is a multicenter, retrospective and prospective (bi-directional) patient chart review, observational (non-interventional) study, in the patients treated within the Latin America EAP. The study is planned to be conducted at oncology services distributed in Argentina and Brazil. Its multicenter nature aims to improve the representativeness of the study population in the region. Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria in the sites previously involved in the EAP. The follow-up data collection will be performed using a combination of medical records and patients' interviews. For patients that had interrupted the treatment before study start, the study comprises a single study visit with retrospective data collection from medical charts, followed by follow-up overall survival status, progression-free survival and time to next treatment performed by medical chart review or by phone call at month 12, month 24 and month 36 from the first dose of niraparib. For those that were still in treatment, data collection will be performed during the regular visits to the services involved in the study, using a combination of medical records abstraction and patient's interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated within the EAPs with niraparib for ovarian cancer | This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety profile | To evaluate the safety profile, including dose modifications, of niraparib in patients with advanced ovarian cancer in response following first-line platinum-based chemotherapy treated in a real-world setting within the EAP. | through study completion, an average of 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult female patients with diagnosis of advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy, treated within the niraparib EAP.
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| Name | Affiliation | Role |
|---|---|---|
| Angélica Nogueira Rodrigues | Latin American Cooperative Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COIP - Centro Oncologico Integral Pampeano | Santa Rosa | La Pampa Province | Argentina | |||
| Sanatorio de la Mujer |
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| Rosario |
| Santa Fe Province |
| Argentina |
| Fundacion Medica de Rio Negro y Neuquen | Neuquén | Argentina |
| CINPAM - Centro Integrado de Pesquisa da Amazônia | Manaus | Amazonas | 69.020-030 | Brazil |
| Hospital Santa Rita de Cássia | Vitória | Espírito Santo | 29.043-260 | Brazil |
| NOB - Núcleo de Oncologia da Bahia (Oncoclínicas) | Salvador | Estado de Bahia | 40.170-110 | Brazil |
| Oncocentro de Minas Gerais (Oncoclínicas) | Belo Horizonte | Minas Gerais | 30.360-680 | Brazil |
| IOP Pesquisa - Instituto de Oncologia do Paraná | Curitiba | Paraná | 80.040-170 | Brazil |
| HMV - Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90.035-000 | Brazil |
| CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90.610-000 | Brazil |
| Hospital de Amor de Barretos | Barretos | São Paulo | 14.784-400 | Brazil |
| Hospital Amaral Carvalho de Jaú | Jaú | São Paulo | 17.210-120 | Brazil |
| ICESP - Instituto do Câncer do Estado de São Paulo | São Paulo | 01.246-000 | Brazil |
| BP - A Beneficência Portuguesa de São Paulo | São Paulo | 01.323-030 | Brazil |
| Instituto D'Or de Pesquisa e Ensino SP | São Paulo | 04.502-001 | Brazil |
| Pérola Byington Centro de Pesquisa | São Paulo | Brazil |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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