Clinical trial · Observational
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting
NCT04015102CI-TRIAL-00048128completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with Prostate Cancer in community urology practices nationwide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To see how practical it would be to integrate a standard hereditary cancer risk assessment, patient counseling and genetic testing process into the community urology practice setting.
- timeFrame
- 18 weeks per site
- description
- To see how practical it would be to integrate a standard hereditary cancer risk assessment , patient counseling and genetic testing process into the community urology practice setting. Also to evaluate the impact of the integrated process on provider and patient satisfaction. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.
Secondary outcomes (1)
- measure
- To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process.
- timeFrame
- 18 weeks
- description
- To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years of age or older at time of enrollment * Affected with Prostate Cancer (newly or previously diagnosed patients). * Presents for a medical care visit and meets eligibility criteria for hereditary cancer genetic testing, based on personal and family cancer history and NCCN Practice Guidelines in Oncology (Prostate Cancer) * Able to understand informed consent and agrees to participate in the registry. Exclusion Criteria: * Minors (younger than 18 years of age) * Have had previous genetic testing for Hereditary Breast and Ovarian Cancer or Lynch Syndrome, or have previously undergone hereditary multi-gene, pan-cancer, or panel testing. * Unable to provide routine clinical informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.