Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)
3 de febrero de 2015 actualizado por: Rebecca Robinson, The Christie NHS Foundation Trust
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.
This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.
Descripción general del estudio
Estado
Suspendido
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Anticipado)
50
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.
Ubicaciones de estudio
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Manchester, Reino Unido, M20 4BX
- The Christie NHS Foundation Trust
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.
Descripción
Inclusion Criteria:
- Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- Age 18 or older
- Performance Status 0-2
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Exclusion Criteria:
- Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- Radio-immunotherapy within the last 8 weeks.
- Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Biomarker and health economics
Biomarkers will be taken throughout cycle 1.
Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.
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Biomarkers CK18 and FLT3 Ligand will be collected
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
Periodo de tiempo: day 3
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to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
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day 3
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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number of hospital admissions for febrile neutropenia
Periodo de tiempo: end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
Periodo de tiempo: End of study chemotherapy at approximately 6 months
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End of study chemotherapy at approximately 6 months
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Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
Periodo de tiempo: End of chemotherapy at approximately 6 months
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End of chemotherapy at approximately 6 months
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Number of total days delay in receiving chemotherapy treatment compared to planned delivery
Periodo de tiempo: end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
Periodo de tiempo: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
Periodo de tiempo: end of study chemotherapy at approximately 6 months
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end of study chemotherapy at approximately 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Alastair Greystoke, The Christie NHS Foundation Trust
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 octubre de 2013
Finalización primaria (Anticipado)
1 de noviembre de 2015
Fechas de registro del estudio
Enviado por primera vez
9 de agosto de 2013
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2013
Publicado por primera vez (Estimar)
14 de agosto de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11_DOG05_99
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. .
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