- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02903277
National Observatory of Chronic Myeloid Leukemia Adolescent and Young Adults Treated With Tyrosine Kinase Inhibitors in First Intent
12 de septiembre de 2016 actualizado por: Centre Hospitalier Universitaire de Nice
The median age of onset of chronic myeloid leukemia (CML) in chronic phase PC is about 60 years.
However CML affects all age groups including 18-25 year olds, called adult-young adolescents (AJA).
In France, there is no record of CML and especially not for this particular population, only a European Register of CML in children up to 18 years has been set up under the coordination of Professor "Frederic Millot", pediatrics, CHU Poitiers.
Malignancies diagnosed in this population usually have characteristics, evolution, therapeutic strategies with tyrosine kinase inhibitors (TKIs) are a real therapeutic revolution with an overall survival very significantly augmented but at present only a minority of patients may one day consider a final judgment of treatment.
AJA are the most exposed patients to the complications, the socio-economic repercussions, professional and personal of a very long-term treatment.
But there is little data in the literature concerning this population.
Two studies show that diagnosis of CML presents with poor prognostic factors (high skoal), the observed responses are poorer compared to older patients but it is accompanied difference in survival in all cases with a decline of about 70 mois.
However, these studies have focused solely on the patients included in the study receiving optimized treatment is not the standard treatment at the time.
It is clearly demonstrated that the inclusion in a study brings a benefit to the patient.
However, the majority of AJA are not included in a study.
The investigators therefore want to describe the AYA population of CML in France and compare the evolution of patients included or not in a protocol.
The investigators also want to investigate specific issues of the age of these patients as the reproductive desire.
Indeed, while it does not seem to be any risk of teratogenicity for men treated with ITK, this risk is clearly established for women and requires specific supported.
Another important point is that of the quality of life.
The state of physical and mental health and his feelings, physical activity and its limitations and well-being was assessed by the SF-3612 questionnaire.
The results of this analysis were compared with those already obtained for the general population (not representative of Italian adults with cancer sample) and adjusted for sex, age, geographic region, marital status and education level .
There seems to be young people and women who express a feeling more pejorative.
This does not only covers the frequency of side effects but also on physical activity and well-being.
the affected population will be noted that that is particularly involved in the social, professional and in the development of his personal life.
The impact of treatment on quality of life must be considered under penalty of seeing the difficulties of compliance.
But several studies have demonstrated the negative impact of poor adherence in response to treatments .
Descripción general del estudio
Estado
Desconocido
Condiciones
Tipo de estudio
De observación
Inscripción (Anticipado)
150
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 30 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
All patients aged 18 to 30 years diagnosed with CML treated with a frontline ITK will be included in the observatory after collecting their non-opposition.
In the retrospective part of the study, we will collect data from dead or lost to patients.
Descripción
Inclusion Criteria:
- patients aged 18 to 30 years
- patients diagnosed with CML treated with TKI first line
- collecting their non-opposition
Exclusion Criteria:
- none
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Collect clinical data of diagnosis of the AJA CML patients
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Treatment choices of the AJA CML patients
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Tolerance of treatments
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Adherence to therapeutic response
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Evolution of the disease
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Survival of the patient
Periodo de tiempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2016
Finalización primaria (Anticipado)
1 de noviembre de 2016
Finalización del estudio (Anticipado)
1 de noviembre de 2021
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2016
Publicado por primera vez (Estimar)
16 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de septiembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
12 de septiembre de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-PP-10
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. .