- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02160366
Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Molecular Profiling/Deep Sequencing:
Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.
Biomarker Data:
A characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.
Study Participation:
If you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.
Researchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.
The data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.
In addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
Your name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.
Use of Samples:
Before your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.
Your tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.
Length of Study:
Your participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.
This is an investigational study.
Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- University of Texas MD Anderson Cancer Center
-
-
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
Inclusion Criteria:
1. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.
Exclusion Criteria:
n/a
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Biomarker/Molecular Data Collection and Analyzation
Advanced cancer participants
|
Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue.
Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of Biomarker Profiling to Treatment Outcome
Periodo de tiempo: 2 months
|
For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable.
Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.
|
2 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Filip Janku, MD, PHD, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LAB10-0441
- 3UL1RR024148-04S1 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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 Cánceres avanzados
-
Advanced BionicsTerminadoPérdida auditiva severa a profunda | en usuarios adultos de Advanced Bionics HiResolution™ Bionic Ear SystemEstados Unidos
Ensayos clínicos sobre Biomarker Research
-
ORIOL BESTARDTerminadoTrasplante de riñón | Infección por CMVEspaña, Bélgica
-
Oregon Health and Science UniversityTerminadoSíndrome del túnel carpianoEstados Unidos
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
University of CalgaryReclutamientoIntolerancia ortostática | Síndrome de taquicardia posturalCanadá
-
Bryan TompsonTerminadoEl Ritmo o Movimiento Dental OrtodóncicoCanadá
-
CochlearReclutamiento
-
Erasmus Medical CenterAún no reclutando
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); University of PennsylvaniaInscripción por invitación
-
Medical University of GrazEuropean CommissionTerminado