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Patient and Provider Perspectives on Genetic Risk Profiling (PPP)

28 de julio de 2026 actualizado por: Royal Marsden NHS Foundation Trust

Exploring the Patient and Provider Perspectives on the Utility of Genetic Risk Profiling for Prostate Cancer in Routine Clinical Practice

A qualitative interview study exploring the patient and provider perspectives on the clinical utility of genetic risk profiling in routine clinical practice. The findings from the study may contribute towards future research and informing clinical practice.

Descripción general del estudio

Estado

Reclutamiento

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

De observación

Inscripción (Estimado)

40

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • London, Reino Unido, SM2 5PT
        • Reclutamiento
        • The Royal Marsden Hospital (Sutton and Chelsea)
        • Contacto:
          • Tarryn Shaw, MSc Genetic Counselling
          • Número de teléfono: 0208 722 4483
          • Correo electrónico: tarryn.shaw@rmh.nhs.uk
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients who have undergone and received a genetic risk profiling result for prostate cancer and healthcare providers who have delivered a genetic risk profiling result for prostate cancer

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

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
Patient participants
Diverse cohort of patients who have undergone genetic risk profiling and have received their results
Interview of participants to gain perspectives and experiences
Provider participants
Healthcare providers who have delivered genetic risk profiling results to patients
Interview of participants to gain perspectives and experiences

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
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.
January 2026 to August 2027

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Elizabeth Bancroft, RN PhD, The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research

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)

1 de mayo de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

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

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Only if participants consent to future research / sharing of research data

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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