Lynch Syndrome Clinical Trial
Official title:
Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2019 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male carrier of mutation in BRCA 1\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2). - WHO performance status 0-2 (Appendix 2) - Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule. - Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part. - Informed written consent must be sought according to ICH/EU GCP, before subject registration. Exclusion Criteria: - Previous cancer with a terminal prognosis of less than five years. - Previous prostate cancer |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center - Beilinson Hospital | Petah Tikva | |
Israel | Rabin Medical Center, Beilinson Hospital | Petah Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting clinically significant prostate cancer among men with genetic predispositions. | within 2 years | ||
Other | Cost effectiveness of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer and clinically significant prostate cancer among men with genetic predispositions. | within 2 years | ||
Other | Impact of genetic mutations (BRCA, Lynch) on lower urinary tract symptoms (IPSS, flow and post void urine residual) and BPH ( benign prostatic hyperplasia). | within 2 years | ||
Other | Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer. | within 2 years | ||
Primary | Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers | within 2 years | ||
Secondary | Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions. | within 2 years |
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