Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02440802
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2015-04-30
Brief Title:
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Feel
Brief Summary:
Androgen deprivation therapy ADT by surgical castration or administration of LHRH agonists or antagonists is the gold-standard systemic treatment of Prostate Cancer The efficacy severity and frequency of side effects of ADT vary from a patient to another The exact cause of this variability is not known however certain genetic polymorphisms affecting enzymes implicated in the synthesis and metabolism of sex-steroids seem to be involved in these processes
To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms affecting genes in the sex-steroid synthesis and metabolism pathway CYP1A1 CYP1B1 CYP19A1 17HSD HSD3B1 AR ESR1 ESRRG IL6 TNF-alpha in men with Prostate Cancer receiving ADT and the possible association between polymorphisms and frequency and severity of side-effects of ADT
To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms affecting genes in the sex-steroid synthesis and metabolism pathway CYP1A1 CYP1B1 CYP19A1 17HSD HSD3B1 AR ESR1 ESRRG IL6 TNF-alpha in men with Prostate Cancer receiving ADT and the possible association between polymorphisms and frequency and severity of side-effects of ADT
Detailed Description:
Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated for a period of at least 6 months will lbe enrolled At 0 3 months and 6 months of ADT Aging Males Symptoms AMS EQ-5D EuroQoL and hot flashes intensity and frequency Moyad scale will be collected as well as routine assessments vital signs blood pressure heart rate weight waist perimeter fat percentage Body Mass Index BMI and routine laboratory assessments Determine genotypes of polymorphisms of interest by pyrosequencing Determine the prevalence of the polymorphisms of interest in the studied population Perform initial assessment of the association between genetic polymorphisms and questionnaire results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None