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| Name | Class |
|---|---|
| Royal Marsden NHS Foundation Trust | OTHER |
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This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFFECTED |
|
| |
| UNAFFECTED (Cohort now closed, recruitment complete) | - Aged >30 and with a family history defined as::
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate cancer risk gene panel | Genetic | A list of genes created by study experts, thought to increase the risk of prostate cancer from from review previous research, this list is regularly reviewed for accuracy |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of genetic variation in affected men | To determine the prevalence of prostate cancer (PrCa) specific genetic variation in men with: (a)young onset PrCa; (b) metastatic PrCa; (c) men with PrCa and a family history of PrCa compared with controls. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of genetic variation in unaffected men | To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls. | Through study completion, an average of 1 year |
| Prostate Cancer genetic variation on clinical outcome |
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Inclusion Criteria:
Affected cohort:
Unaffected cohort: (This cohort is no longer recruiting, it has completed recruitment)
Aged >30 and with a family history defined as:
Exclusion Criteria:
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There are two pathways for men to be approached about this study; first eligible men will be identified and approached by their clinical team in Urology and Uro-Oncology clinics at the Royal Marsden. Second, men already under the care of the Oncogenetics Research team due to their family history of prostate cancer and who meet the eligibility criteria will be given information about the study as deemed appropriate by the research clinician who has been managing their care (Research Nurse or Clinical Research Fellow).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden Hosital, | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Whole blood DNA or Saliva sample is collected from the participant for genetic analysis
To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups. |
| Through study completion, an average of 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |