- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02984423
FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study (FLABRA)
Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across understudied ethnic groups in Latin America. Secondary objectives of the study are to evaluate the prevalence of sBRCAm versus gBRCAm in newly diagnosed ovarian cancer patients and to describe current ovarian cancer counselling and treatment approach patterns at front line setting across Latin America.
In the Screening Visit, consecutive eligible patients who have been newly diagnosed with ovarian cancer within the last 120 days will be invited to participate. After having provided consent, patients will be asked to provide ethnicity and cancer family history information. Patients will self-identify to one or more of the defined broad ethnic groups (Native American, Afro-Caribbean, Caucasian) based on self-reported ancestry information. Archived tumor blocks or twenty 10-µm sections from eligible patients will be requested from the local pathology lab and used for BRCA mutations testing.
Patient medical records will be reviewed for data relevant to the ovarian cancer diagnosis, including basic demographics, medical history, and treatment history.
During the Devolution Visit, results of the tumor BRCA test will be communicated to the patient, and information about counselling approach and treatment plan will be recorded in the medical chart. This Devolution Visit will be the last visit for this study for the cases of non-mutated patients. For patients for whom a BRCA mutation have been identified in tumor, additional test in blood looking for the specific point mutation found in tumor will be performed to investigate if these patients harbor a germline BRCA mutation. For these patients a further visit will be organised to communicate results to the patient and data regarding germline test results will be recorded in the medical chart of the patient.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Buenos Aires, Argentina, C1118AAT
- Research Site
-
Buenos Aires, Argentina, C1431FWO
- Research Site
-
Caba, Argentina, C1426ANZ
- Research Site
-
Cordoba, Argentina, 5000
- Research Site
-
La Rioja, Argentina, 5300
- Research Site
-
Resistencia, Argentina, 3500
- Research Site
-
Rosario, Argentina, S2000KZE
- Research Site
-
-
-
-
-
Barretos, Brasil, 14784-400
- Research Site
-
Belo Horizonte, Brasil, 30130-100
- Research Site
-
Curitiba, Brasil, 81520-060
- Research Site
-
Fortaleza, Brasil, 60336-045
- Research Site
-
Fortaleza, Brasil, 60430-230
- Research Site
-
Jaú, Brasil, 17210-120
- Research Site
-
Porto Alegre, Brasil, 90610-000
- Research Site
-
Rio de Janeiro, Brasil, 22793-080
- Research Site
-
Rio de Janeiro, Brasil, 20560-120
- Research Site
-
Salvador, Brasil, 41950-610
- Research Site
-
Sao Paulo, Brasil, 01246-000
- Research Site
-
São Paulo, Brasil, 01317-000
- Research Site
-
-
-
-
-
Bogota, Colombia
- Research Site
-
Bogotá, Colombia
- Research Site
-
Cali, Colombia
- Research Site
-
Medellín, Colombia
- Research Site
-
-
-
-
-
México, México, 1400
- Research Site
-
-
-
-
-
Ciudad de Panama, Panamá
- Research Site
-
-
-
-
-
Lima, Perú, LIMA 11
- Research Site
-
Lima, Perú, 0051
- Research Site
-
San Isidro, Perú
- Research Site
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclussion criteria:
- Be able and willing to sign the informed consent form
- Be older than 18 years of age
Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:
- standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulking and or
- surgical resection and radiographic evidence consistent with Stage 3 or 4 ovarian cancer
- paracentesis or biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer (normal appearing pancreas, liver, and gastrointestinal tract)
- Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10 microm sections
- Have a diagnosis that is within 120 days of informed consent
Exclusion criteria:
- Have a diagnosis of any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
- Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population
Periodo de tiempo: up to one year
|
FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across understudied ethnic groups in Latin America
|
up to one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
Periodo de tiempo: up to one year
|
To estimate the prevalence of gBRCAm in newly diagnosed ovarian cancer patients who have a BRCA mutation identified in the tumor sample, in LATAM population, and by ethnic sub-groups
|
up to one year
|
Counselling approach in ovarian cancer across Latinamerican countries
Periodo de tiempo: up to one year
|
To describe all professionals participating in this process, and time for the approach
|
up to one year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D0817R00002
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de ovarios
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento