- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Tarryn Shaw, MSc
- Numero di telefono: 020 8661 3375
- Email: tarryn.shaw@rmh.nhs.uk
Backup dei contatti dello studio
- Nome: Elizabeth Bancroft, RN PhD
- Numero di telefono: 02087224483
- Email: elizabeth.bancroft@rmh.nhs.uk
Luoghi di studio
-
-
-
London, Regno Unito, SM2 5PT
- Reclutamento
- The Royal Marsden Hospital (Sutton and Chelsea)
-
Contatto:
- Tarryn Shaw, MSc Genetic Counselling
- Numero di telefono: 0208 722 4483
- Email: tarryn.shaw@rmh.nhs.uk
-
Contatto:
- Elizabeth Bancroft, RN PhD
- Numero di telefono: 0208 722 4483
- Email: elizabeth.bancroft@rmh.nhs.uk
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Elizabeth Bancroft, RN PhD, The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CCR6285
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .