Spots Global Cancer Trial Database for A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
Official Title: A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
Study ID: NCT05857397
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
COIP - Centro Oncologico Integral Pampeano, Santa Rosa, La Pampa, Argentina
Sanatorio de la Mujer, Rosario, Santa Fé, Argentina
Fundacion Medica de Rio Negro y Neuquen, Neuquén, , Argentina
CINPAM - Centro Integrado de Pesquisa da Amazônia, Manaus, Amazonas, Brazil
NOB - Núcleo de Oncologia da Bahia (Oncoclínicas), Salvador, Bahia, Brazil
Hospital Santa Rita de Cássia, Vitória, Espirito Santo, Brazil
Oncocentro de Minas Gerais (Oncoclínicas), Belo Horizonte, Minas Gerais, Brazil
IOP Pesquisa - Instituto de Oncologia do Paraná, Curitiba, Paraná, Brazil
HMV - Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor de Barretos, Barretos, São Paulo, Brazil
Hospital Amaral Carvalho de Jaú, Jaú, São Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo, , Brazil
BP - A Beneficência Portuguesa de São Paulo, São Paulo, , Brazil
Instituto D'Or de Pesquisa e Ensino SP, São Paulo, , Brazil
Pérola Byington Centro de Pesquisa, São Paulo, , Brazil
Contact Details
Name: Angélica Nogueira Rodrigues
Affiliation: Latin American Cooperative Oncology Group
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
