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出境医 / 临床实验 / A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
Study Description
Brief Summary:
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.
| Condition or disease |
|---|
| Prostate Cancer |
Detailed Description:
Genes linked to hereditary cancer syndromes have been associated with increased risk for prostate cancer (PrCa), earlier disease onset and increased disease aggressiveness.1,2 Ascertaining family cancer history and hereditary risk in men diagnosed with PrCa can help inform medical management decisions. Recently published National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (v3.2018)3 and Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019)4 as well as the American Urological Association Guideline for Clinically Localized Prostate Cancer (2017)5 recommend appropriate counseling and genetic testing for men who are at increased hereditary cancer risk, based upon personal or family history. Genetic testing for patients with metastatic prostate cancer is now standard of care per NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019) guidelines4. NCCN Prostate Cancer Guidelines (v3.2018)3 recommend obtaining a cancer-focused family history at diagnosis and consideration of germline genetic testing in multiple risk groups. Community urology practices can support guideline-aligned care by performing routine hereditary cancer risk assessment (HCRA), patient counseling and, when appropriate, genetic testing. 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 PrCa in community urology practices nationwide.
Study Design
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 255 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting |
| Actual Study Start Date : | March 6, 2019 |
| Actual Primary Completion Date : | October 21, 2020 |
| Actual Study Completion Date : | October 30, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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. [ Time Frame: 18 weeks per site ]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 Outcome Measures :
- 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. [ Time Frame: 18 weeks ]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.
Biospecimen Retention: Samples With DNA
Blood sample required for myRisk test
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Prostate Cancer patients, at least 18 years or older, who meet NCCN guidelines and eligibility criteria, who have a scheduled set appointment at Community Urology practices.
Criteria
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.
Contacts and Locations
Locations
| United States, Arkansas | |
| Arkansas Urology | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Urology Associates of Central California | |
| Fresno, California, United States, 93720 | |
| United States, Indiana | |
| Urologic Specialists of Northwest Indiana | |
| Merrillville, Indiana, United States, 46410 | |
| United States, Michigan | |
| Comprehensive Urology | |
| Royal Oak, Michigan, United States, 48073 | |
| Comprehensive Urology | |
| Waterford, Michigan, United States, 48328 | |
| United States, New York | |
| Associated Medical Professionals of New York | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Associated Urologists of North Carolina | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Oregon | |
| Oregon Urology Institute | |
| Springfield, Oregon, United States, 97477 | |
| United States, Pennsylvania | |
| MidLantic Urology | |
| Bala-Cynwyd, Pennsylvania, United States, 19004 | |
| United States, South Carolina | |
| Carolina Urologic Research Center | |
| Myrtle Beach, South Carolina, United States, 29572 | |
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Carolina Urologic Research Center
Investigators
| Principal Investigator: | Neal Shore, MD | Carolina Urologic Research Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 26, 2019 | ||||
| First Posted Date | July 10, 2019 | ||||
| Last Update Posted Date | November 5, 2020 | ||||
| Actual Study Start Date | March 6, 2019 | ||||
| Actual Primary Completion Date | October 21, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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. [ Time Frame: 18 weeks per site ] 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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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. [ Time Frame: 18 weeks ] 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.
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | A Registry for Hereditary Cancer Risk Assessment and Genetic Testing | ||||
| Official Title | A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting | ||||
| Brief Summary | 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. | ||||
| Detailed Description | Genes linked to hereditary cancer syndromes have been associated with increased risk for prostate cancer (PrCa), earlier disease onset and increased disease aggressiveness.1,2 Ascertaining family cancer history and hereditary risk in men diagnosed with PrCa can help inform medical management decisions. Recently published National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (v3.2018)3 and Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019)4 as well as the American Urological Association Guideline for Clinically Localized Prostate Cancer (2017)5 recommend appropriate counseling and genetic testing for men who are at increased hereditary cancer risk, based upon personal or family history. Genetic testing for patients with metastatic prostate cancer is now standard of care per NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019) guidelines4. NCCN Prostate Cancer Guidelines (v3.2018)3 recommend obtaining a cancer-focused family history at diagnosis and consideration of germline genetic testing in multiple risk groups. Community urology practices can support guideline-aligned care by performing routine hereditary cancer risk assessment (HCRA), patient counseling and, when appropriate, genetic testing. 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 PrCa in community urology practices nationwide. | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 3 Years | ||||
| Biospecimen | Retention: Samples With DNA Description:
Blood sample required for myRisk test
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Prostate Cancer patients, at least 18 years or older, who meet NCCN guidelines and eligibility criteria, who have a scheduled set appointment at Community Urology practices. | ||||
| Condition | Prostate Cancer | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
255 | ||||
| Original Estimated Enrollment |
500 | ||||
| Actual Study Completion Date | October 30, 2020 | ||||
| Actual Primary Completion Date | October 21, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04015102 | ||||
| Other Study ID Numbers | URO-012 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Myriad Genetic Laboratories, Inc. | ||||
| Study Sponsor | Myriad Genetic Laboratories, Inc. | ||||
| Collaborators | Carolina Urologic Research Center | ||||
| Investigators |
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| PRS Account | Myriad Genetic Laboratories, Inc. | ||||
| Verification Date | November 2020 | ||||
