Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505356
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association With Disease Stage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations With Disease Stage and Clinical Presentation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Identify the local inflammatory response in prostate tissue and the systemic response in the blood of patients with prostate cancer depending on the stage of the disease and evaluate their prognostic value
2 Identify the spectrum of microorganisms and antibiotic resistance in patients with prostate cancer prior to prostate biopsy and assess the risk of complications when using Ciprofloxacin and Fosfomycin
3 Determine the significance of GAS5 JAZF1 and CTBP2 gene polymorphisms in the development of prostate cancer
4 Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer
2 Identify the spectrum of microorganisms and antibiotic resistance in patients with prostate cancer prior to prostate biopsy and assess the risk of complications when using Ciprofloxacin and Fosfomycin
3 Determine the significance of GAS5 JAZF1 and CTBP2 gene polymorphisms in the development of prostate cancer
4 Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer
Detailed Description:
Goal 1 Identify Local Inflammatory Response in Prostate Tissue and Systemic Response in the Blood of Patients with Prostate Cancer Depending on the Stage of the Disease and Evaluate Their Prognostic Value
Objective To investigate and characterize both local and systemic inflammatory responses in prostate cancer patients at various disease stages
Approach
Local Inflammatory Response Examine prostate tissue samples to identify markers and levels of inflammation This involves histological analysis and possibly molecular assays eg PCR immunohistochemistry
Systemic Inflammatory Response Measure inflammatory markers in the blood such as C-reactive protein CRP interleukins eg IL-6 and other cytokines
Disease Staging Correlate these inflammatory responses with the stage of prostate cancer eg localized advanced metastatic to understand the progression of the disease
Prognostic Value Analyze the data to determine if these inflammatory markers can predict disease progression response to treatment and overall prognosis
Expected Outcome Establish a comprehensive profile of inflammatory responses associated with different stages of prostate cancer and identify potential prognostic biomarkers
Goal 2 Identify the Spectrum of Microorganisms and Antibiotic Resistance in Patients with Prostate Cancer Prior to Prostate Biopsy and Assess the Risk of Complications When Using Ciprofloxacin and Fosfomycin
Objective To profile the microbial flora and antibiotic resistance in prostate cancer patients before biopsy and evaluate the safety and efficacy of Ciprofloxacin and Fosfomycin
Approach
Microbial Spectrum Collect and analyze urine prostatic fluid and other relevant samples to identify bacterial species present using culture methods and molecular techniques
Antibiotic Resistance Test the identified microorganisms for resistance to common antibiotics focusing on Ciprofloxacin and Fosfomycin
Risk Assessment Review patient outcomes post-biopsy to assess the incidence of complications such as infection and adverse reactions particularly in relation to the use of the studied antibiotics
Data Analysis Correlate microbial profiles and resistance patterns with clinical outcomes to determine the risk factors for complications
Expected Outcome Develop guidelines for antibiotic use in prostate biopsy procedures based on microbial and resistance profiles to minimize the risk of complications
Goal 3 Determine the Significance of GAS5 JAZF1 and CTBP2 Gene Polymorphism in the Development of Prostate Cancer
Objective To investigate the role of specific gene polymorphisms GAS5 JAZF1 and CTBP2 in the susceptibility to and development of prostate cancer
Approach
Genetic Analysis Collect DNA samples from prostate cancer patients and a control group Perform genotyping to identify polymorphisms in the GAS5 JAZF1 and CTBP2 genes
Association Studies Conduct statistical analyses to compare the frequency of these polymorphisms in patients versus controls Assess their correlation with the presence and severity of prostate cancer
Functional Studies Where possible explore the biological impact of these polymorphisms on gene expression and function potentially through in vitro or in vivo models
Expected Outcome Identify genetic markers that contribute to prostate cancer risk enhancing understanding of disease mechanisms and potential targets for intervention
Goal 4 Evaluate the Associations of One Gene Polymorphism with the Clinical Course of Disease in Patients with Prostate Cancer
Objective To determine how a specific gene polymorphism influences the clinical trajectory of prostate cancer
Approach
Polymorphism Selection Choose a gene polymorphism of interest potentially based on findings from previous research or Goals 1-3
Clinical Data Collection Gather comprehensive clinical data from prostate cancer patients including disease stage progression treatment response and outcomes
Genotype-Phenotype Correlation Perform genetic testing to identify the presence of the polymorphism in these patients Correlate the genetic data with clinical parameters to assess associations
Statistical Analysis Use appropriate statistical methods to determine the significance of the associations between the polymorphism and various clinical aspects of prostate cancer
Expected Outcome Gain insights into how genetic variations can affect the progression and treatment response in prostate cancer potentially guiding personalized treatment approaches
Prostate Cancer and Biopsy Related Acronyms
1 TRUS Transrectal Ultrasound
A medical imaging technique used to visualize the prostate gland and guide the biopsy needle
2 PSA Prostate-Specific Antigen
A protein produced by the prostate gland elevated levels of which can indicate prostate cancer
3 Gleason Score
A grading system used to determine the aggressiveness of prostate cancer based on the microscopic appearance of prostate tissue
Genetic and Molecular Biology Acronyms
1 GAS5 Growth Arrest Specific 5
A long non-coding RNA involved in regulating cell growth and apoptosis often studied in cancer research
2 JAZF1 JAZF Zinc Finger 1
A gene associated with various cellular processes including transcriptional regulation and potentially linked to cancer
3 CTBP2 C-terminal Binding Protein 2
A protein that functions as a transcriptional co-repressor playing a role in gene expression regulation and cancer
4 PCR Polymerase Chain Reaction
A laboratory technique used to amplify DNA sequences making it easier to study genetic material in detail
5 NGS Next-Generation Sequencing
Advanced sequencing technologies that allow for rapid and detailed sequencing of large amounts of DNA
Inflammatory Markers
1 6Ckine CCL21 Chemokine C-C motif ligand 21
A cytokine involved in the immune response and potentially linked to inflammation in cancer
2 Eotaxin CCL11 Chemokine C-C motif ligand 11
A chemokine that attracts eosinophils and is associated with allergic responses and inflammation
3 Fractalkine CX3CL1 Chemokine C-X3-C motif ligand 1
A chemokine involved in immune cell migration and adhesion playing a role in inflammation and cancer
4 IFN gamma Interferon gamma
A cytokine critical for innate and adaptive immunity against viral and intracellular bacterial infections and for tumor control
5 IL-2 Interleukin 2
A cytokine that promotes the growth and differentiation of T cells important in the immune response
6 IL-6 Interleukin 6
A cytokine involved in inflammation and infection responses also linked to cancer progression
7 IL-8 CXCL8 Interleukin 8
A chemokine that attracts neutrophils and is involved in the inflammatory response
8 IL-10 Interleukin 10
A cytokine with anti-inflammatory properties regulating immune responses
9 IL-18 Interleukin 18
A cytokine that induces interferon gamma production playing a role in inflammation and immune responses
10 MIP-3 beta CCL19 Macrophage Inflammatory Protein 3 beta
A chemokine involved in immune cell trafficking and inflammatory responses
11 PDGF-BB Platelet-Derived Growth Factor BB
A growth factor involved in blood vessel formation and the growth of various cell types
12 TNF alpha Tumor Necrosis Factor alpha
A cytokine involved in systemic inflammation and is part of the immune systems response to cancer
Objective To investigate and characterize both local and systemic inflammatory responses in prostate cancer patients at various disease stages
Approach
Local Inflammatory Response Examine prostate tissue samples to identify markers and levels of inflammation This involves histological analysis and possibly molecular assays eg PCR immunohistochemistry
Systemic Inflammatory Response Measure inflammatory markers in the blood such as C-reactive protein CRP interleukins eg IL-6 and other cytokines
Disease Staging Correlate these inflammatory responses with the stage of prostate cancer eg localized advanced metastatic to understand the progression of the disease
Prognostic Value Analyze the data to determine if these inflammatory markers can predict disease progression response to treatment and overall prognosis
Expected Outcome Establish a comprehensive profile of inflammatory responses associated with different stages of prostate cancer and identify potential prognostic biomarkers
Goal 2 Identify the Spectrum of Microorganisms and Antibiotic Resistance in Patients with Prostate Cancer Prior to Prostate Biopsy and Assess the Risk of Complications When Using Ciprofloxacin and Fosfomycin
Objective To profile the microbial flora and antibiotic resistance in prostate cancer patients before biopsy and evaluate the safety and efficacy of Ciprofloxacin and Fosfomycin
Approach
Microbial Spectrum Collect and analyze urine prostatic fluid and other relevant samples to identify bacterial species present using culture methods and molecular techniques
Antibiotic Resistance Test the identified microorganisms for resistance to common antibiotics focusing on Ciprofloxacin and Fosfomycin
Risk Assessment Review patient outcomes post-biopsy to assess the incidence of complications such as infection and adverse reactions particularly in relation to the use of the studied antibiotics
Data Analysis Correlate microbial profiles and resistance patterns with clinical outcomes to determine the risk factors for complications
Expected Outcome Develop guidelines for antibiotic use in prostate biopsy procedures based on microbial and resistance profiles to minimize the risk of complications
Goal 3 Determine the Significance of GAS5 JAZF1 and CTBP2 Gene Polymorphism in the Development of Prostate Cancer
Objective To investigate the role of specific gene polymorphisms GAS5 JAZF1 and CTBP2 in the susceptibility to and development of prostate cancer
Approach
Genetic Analysis Collect DNA samples from prostate cancer patients and a control group Perform genotyping to identify polymorphisms in the GAS5 JAZF1 and CTBP2 genes
Association Studies Conduct statistical analyses to compare the frequency of these polymorphisms in patients versus controls Assess their correlation with the presence and severity of prostate cancer
Functional Studies Where possible explore the biological impact of these polymorphisms on gene expression and function potentially through in vitro or in vivo models
Expected Outcome Identify genetic markers that contribute to prostate cancer risk enhancing understanding of disease mechanisms and potential targets for intervention
Goal 4 Evaluate the Associations of One Gene Polymorphism with the Clinical Course of Disease in Patients with Prostate Cancer
Objective To determine how a specific gene polymorphism influences the clinical trajectory of prostate cancer
Approach
Polymorphism Selection Choose a gene polymorphism of interest potentially based on findings from previous research or Goals 1-3
Clinical Data Collection Gather comprehensive clinical data from prostate cancer patients including disease stage progression treatment response and outcomes
Genotype-Phenotype Correlation Perform genetic testing to identify the presence of the polymorphism in these patients Correlate the genetic data with clinical parameters to assess associations
Statistical Analysis Use appropriate statistical methods to determine the significance of the associations between the polymorphism and various clinical aspects of prostate cancer
Expected Outcome Gain insights into how genetic variations can affect the progression and treatment response in prostate cancer potentially guiding personalized treatment approaches
Prostate Cancer and Biopsy Related Acronyms
1 TRUS Transrectal Ultrasound
A medical imaging technique used to visualize the prostate gland and guide the biopsy needle
2 PSA Prostate-Specific Antigen
A protein produced by the prostate gland elevated levels of which can indicate prostate cancer
3 Gleason Score
A grading system used to determine the aggressiveness of prostate cancer based on the microscopic appearance of prostate tissue
Genetic and Molecular Biology Acronyms
1 GAS5 Growth Arrest Specific 5
A long non-coding RNA involved in regulating cell growth and apoptosis often studied in cancer research
2 JAZF1 JAZF Zinc Finger 1
A gene associated with various cellular processes including transcriptional regulation and potentially linked to cancer
3 CTBP2 C-terminal Binding Protein 2
A protein that functions as a transcriptional co-repressor playing a role in gene expression regulation and cancer
4 PCR Polymerase Chain Reaction
A laboratory technique used to amplify DNA sequences making it easier to study genetic material in detail
5 NGS Next-Generation Sequencing
Advanced sequencing technologies that allow for rapid and detailed sequencing of large amounts of DNA
Inflammatory Markers
1 6Ckine CCL21 Chemokine C-C motif ligand 21
A cytokine involved in the immune response and potentially linked to inflammation in cancer
2 Eotaxin CCL11 Chemokine C-C motif ligand 11
A chemokine that attracts eosinophils and is associated with allergic responses and inflammation
3 Fractalkine CX3CL1 Chemokine C-X3-C motif ligand 1
A chemokine involved in immune cell migration and adhesion playing a role in inflammation and cancer
4 IFN gamma Interferon gamma
A cytokine critical for innate and adaptive immunity against viral and intracellular bacterial infections and for tumor control
5 IL-2 Interleukin 2
A cytokine that promotes the growth and differentiation of T cells important in the immune response
6 IL-6 Interleukin 6
A cytokine involved in inflammation and infection responses also linked to cancer progression
7 IL-8 CXCL8 Interleukin 8
A chemokine that attracts neutrophils and is involved in the inflammatory response
8 IL-10 Interleukin 10
A cytokine with anti-inflammatory properties regulating immune responses
9 IL-18 Interleukin 18
A cytokine that induces interferon gamma production playing a role in inflammation and immune responses
10 MIP-3 beta CCL19 Macrophage Inflammatory Protein 3 beta
A chemokine involved in immune cell trafficking and inflammatory responses
11 PDGF-BB Platelet-Derived Growth Factor BB
A growth factor involved in blood vessel formation and the growth of various cell types
12 TNF alpha Tumor Necrosis Factor alpha
A cytokine involved in systemic inflammation and is part of the immune systems response to cancer
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