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Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials (CALIBRATE)

19 de julio de 2019 actualizado por: CCTU- Cancer Theme
This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an early phase clinical trial.

Descripción general del estudio

Estado

Desconocido

Condiciones

Descripción detallada

Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with, apparently, similar characteristics such as site of origin. This variability in response can in some cases be explained by the genetic profile of the tumour. Therefore, studying the relationship between the molecular profiles of individual cancers and the response to therapy over time is of crucial importance in drug development. However, this endeavour is hampered by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours are at anatomical sites which make biopsy difficult / hazardous which is in addition to the discomfort of a biopsy procedure. Therefore, this study will explore the potential of the circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.

For patients recruited to early phase clinical trials of experimental therapies, archival tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) will be collected according to the individual schedule of each clinical trial.

Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles, which may include analyses of mutational profiles, copy number variations, translocations, chromosomal rearrangements and/or epigenetic profiles.

Molecular profiling of archival and fresh tumour biopsies will also be carried out to study the correlation with cell-free and ctDNA samples and investigate the potential predictor response/resistance to treatment.

Tipo de estudio

De observación

Inscripción (Anticipado)

100

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

  • Reino Unido
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
        • Reclutamiento
        • Cambridge University Hospitals NHS Foundation Trust
        • Contacto:
        • Investigador principal:
          • Richard Baird
        • Sub-Investigador:
          • Simon Pacey

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

All the patients potentially eligible for early phase experimental therapeutic trials will be invited to take part in this study.

Descripción

Inclusion criteria:

  • Histological or cytological confirmation of cancer
  • Patient being considered for participation in an experimental therapeutic trials
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study)

Exclusion criteria:

  • Age below 18 years old
  • Patient not physically and mentally able to give informed consent.

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
Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials.
Periodo de tiempo: From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 months.
ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acceptability of research sampling
Periodo de tiempo: Optional fresh tissue biopsies are planned to be taken at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Acceptability of research tumour biopsies will be assessed by providing a patient with an 'Acceptability Questionnaire' pre and post biopsy.
Optional fresh tissue biopsies are planned to be taken at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Safety of tumour biopsies for patients with cancer on experimental therapeutic trials
Periodo de tiempo: Assessed at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Serious Adverse events at least possibly related to the research biopsy procedure will be collected prospectively. In addition, information related to the medical history and biopsy procedure will be recorded at the different time points.
Assessed at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Gene Mutation profiles in ctDNA and tumour biopsies (where available) over time for patients with cancer on experimental therapeutic trials
Periodo de tiempo: From baseline, at the time points specified in Outcomes 1 and 2, until the end of study, defined as 'disease progression or evidence of unacceptable toxicity', for up to 100 months.
Gene mutation profiles will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
From baseline, at the time points specified in Outcomes 1 and 2, until the end of study, defined as 'disease progression or evidence of unacceptable toxicity', for up to 100 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CCTU- Cancer Theme

Colaboradores

AstraZeneca

Investigadores

  • Investigador principal: Richard Baird, Cambridge University Hospitals 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 (Actual)

8 de diciembre de 2014

Finalización primaria (Anticipado)

30 de marzo de 2020

Finalización del estudio (Anticipado)

30 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

17 de marzo de 2016

Primero enviado que cumplió con los criterios de control de calidad

13 de diciembre de 2016

Publicado por primera vez (Estimar)

16 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

19 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • CALIBRATE (Immune Tolerance Network)

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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