Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT06505356
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-13
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
Sponsor:
Edgaras Burzinskis
Organization:
Study Overview
Official Title:
Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
Last Known Status:
None
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:
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 (e.g., PCR, immunohistochemistry).
* Systemic Inflammatory Response: Measure inflammatory markers in the blood, such as C-reactive protein (CRP), interleukins (e.g., IL-6), and other cytokines.
* Disease Staging: Correlate these inflammatory responses with the stage of prostate cancer (e.g., 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 system's 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 (e.g., PCR, immunohistochemistry).
* Systemic Inflammatory Response: Measure inflammatory markers in the blood, such as C-reactive protein (CRP), interleukins (e.g., IL-6), and other cytokines.
* Disease Staging: Correlate these inflammatory responses with the stage of prostate cancer (e.g., 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 system's response to cancer.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: