Trial Title:
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
NCT ID:
NCT05857397
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Observational study
Description:
This is an observational study; patients will not be exposed to clinical interventions
different from those belonging to the standard of care.
Arm group label:
Patients treated within the EAPs with niraparib for ovarian cancer
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with advanced OC in response following first line platinum-based
chemotherapy who were treated with niraparib within the EAP in Argentina and Brazil;
- Patients who have received at least one dose of niraparib in the EAP.
Exclusion Criteria:
- Patients without medical record available (lost, empty or irretrievable clinical
information).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
COIP - Centro Oncologico Integral Pampeano
Address:
City:
Santa Rosa
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Sebastian Garcia Peralbo
Email:
Principal Investigator
Facility:
Name:
Sanatorio de la Mujer
Address:
City:
Rosario
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Cristina Marcela Nasurdi
Email:
Principal Investigator
Facility:
Name:
Fundacion Medica de Rio Negro y Neuquen
Address:
City:
Neuquén
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Luciano Piazzoni
Email:
Principal Investigator
Facility:
Name:
CINPAM - Centro Integrado de Pesquisa da Amazônia
Address:
City:
Manaus
Zip:
69.020-030
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Gilmara Anne Resende da Silva
Email:
Principal Investigator
Facility:
Name:
NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)
Address:
City:
Salvador
Zip:
40.170-110
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Luciana Castro Garcia Landeiro
Email:
Principal Investigator
Facility:
Name:
Hospital Santa Rita de Cássia
Address:
City:
Vitória
Zip:
29.043-260
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Gláucio Antônio Bertollo
Email:
Principal Investigator
Facility:
Name:
Oncocentro de Minas Gerais (Oncoclínicas)
Address:
City:
Belo Horizonte
Zip:
30.360-680
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Aline Chave Andrade
Email:
Principal Investigator
Facility:
Name:
IOP Pesquisa - Instituto de Oncologia do Paraná
Address:
City:
Curitiba
Zip:
80.040-170
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
João Soares Nunes
Email:
Principal Investigator
Facility:
Name:
HMV - Hospital Moinhos de Vento
Address:
City:
Porto Alegre
Zip:
90.035-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Fernanda Cano Casarotto
Email:
Principal Investigator
Facility:
Name:
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90.610-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Fernanda Bronzon Damian
Email:
Principal Investigator
Facility:
Name:
Hospital de Amor de Barretos
Address:
City:
Barretos
Zip:
14.784-400
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Cristiano de Pádua Souza
Email:
Principal Investigator
Facility:
Name:
Hospital Amaral Carvalho de Jaú
Address:
City:
Jaú
Zip:
17.210-120
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Patrícia Medeiros Milhomem Beato
Email:
Principal Investigator
Facility:
Name:
ICESP - Instituto do Câncer do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01.246-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Maria Del Pilar Esteves Diz
Email:
Principal Investigator
Facility:
Name:
BP - A Beneficência Portuguesa de São Paulo
Address:
City:
São Paulo
Zip:
01.323-030
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Graziela Zibetti Dal Molin
Email:
Principal Investigator
Facility:
Name:
Instituto D'Or de Pesquisa e Ensino SP
Address:
City:
São Paulo
Zip:
04.502-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Vanessa da Costa Miranda
Email:
Principal Investigator
Facility:
Name:
Pérola Byington Centro de Pesquisa
Address:
City:
São Paulo
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
André Mattar
Email:
Principal Investigator
Start date:
July 21, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Latin American Cooperative Oncology Group
Agency class:
Other
Collaborator:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
Latin American Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857397
