- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07741929
Patient and Provider Perspectives on Genetic Risk Profiling (PPP)
Exploring the Patient and Provider Perspectives on the Utility of Genetic Risk Profiling for Prostate Cancer in Routine Clinical Practice
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prostate cancer is the most prevalent cancer in men in the UK, however there are currently no formalised prostate cancer screening and risk management guidelines. Prostate cancer has a large heritable/genetic component and the combination of genetic alterations that a person inherits has a large influence on their risk. Genetic risk profiling can provide information on whether a person has a higher, average or lower genetic risk to develop prostate cancer. This can help to guide screening and management advice, with people at higher risk benefitting from increased surveillance and interventions, while sparing those at lower risk from unnecessary interventions. It can also provide guidance on potential treatments, prevention and reproductive risks and options. This can tailor and personalise healthcare for patients based on their risk, while also providing economic benefits to the healthcare system. Despite the benefits of genetic risk profiling, there are current concerns pertaining to the readiness for it's implementation into routine clinical practice given the lack of current risk management guidelines and uncertainty pertaining to actionability of results. Further research is essential to inform clinical practice.
This study will explore the perspectives of all stakeholders involved in the testing process, namely patients and healthcare providers who respectively receive and deliver genetic risk profiling results, to explore their viewpoints on the utility of genetic risk profiling in routine clinical practice. The research aims to explore current benefits, limitations, concerns and needs pertaining to genetic risk profiling which may contribute towards future research and clinical practice. Patients and providers who have received or delivered these results will be invited to participate in a once-off interview either at the Royal Marsden Hospital in Chelsea or Sutton or via video/telephone consultation. The research will be funded by the Royal Marsden Cancer Charity over 2 years.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tarryn Shaw, MSc
- Número de teléfono: 020 8661 3375
- Correo electrónico: tarryn.shaw@rmh.nhs.uk
Copia de seguridad de contactos de estudio
- Nombre: Elizabeth Bancroft, RN PhD
- Número de teléfono: 02087224483
- Correo electrónico: elizabeth.bancroft@rmh.nhs.uk
Ubicaciones de estudio
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London, Reino Unido, SM2 5PT
- Reclutamiento
- The Royal Marsden Hospital (Sutton and Chelsea)
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Contacto:
- Tarryn Shaw, MSc Genetic Counselling
- Número de teléfono: 0208 722 4483
- Correo electrónico: tarryn.shaw@rmh.nhs.uk
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Contacto:
- Elizabeth Bancroft, RN PhD
- Número de teléfono: 0208 722 4483
- Correo electrónico: elizabeth.bancroft@rmh.nhs.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Individuals assigned male at birth who are aged 18 and over and who have capacity to consent
- Patients who have undergone genetic risk profiling for prostate cancer and have received their results
- Individuals from diverse backgrounds (age, ethnicity, risk status, etc)
- Healthcare providers who have delivered a genetic risk profiling result for prostate cancer
Exclusion Criteria:
- Individuals who lack capacity to consent
- Individuals deemed unsuitable to recruit based on their poor performance status or current medical condition
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Patient participants
Diverse cohort of patients who have undergone genetic risk profiling and have received their results
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Interview of participants to gain perspectives and experiences
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Provider participants
Healthcare providers who have delivered genetic risk profiling results to patients
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Interview of participants to gain perspectives and experiences
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Data pertaining to the experiences and perspectives of healthcare providers and patients regarding the clinical utility of genetic risk profiling in routine clinical practice, using a qualitative (interview) thematic analysis approach.
Periodo de tiempo: January 2026 to August 2027
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The study findings will provide data pertaining to the current experiences, perspectives, benefits, limitations and challenges patients and providers encounter when receiving and delivering genetic risk profiling results.
The findings can help to highlight areas of concern which need to be addressed, improved and/or implemented prior to clinical implementation of genetic risk profiling into routine clinical care.
The findings can also identify the educational, clinical and/or support needs and may also highlight aspects of clinical care which need to be improved or established (e.g.
screening guidelines, resources, upskilled workforce) prior to the integration of genetic risk profiling into routine clinical practice.
This will ensure that genetic risk profiling is relevant and feasible in terms of improving the clinical care and health seeking behaviours of patients.
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January 2026 to August 2027
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elizabeth Bancroft, RN PhD, The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- CCR6285
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
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