Status:
ENROLLING_BY_INVITATION
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
Lead Sponsor:
Edgaras Burzinskis
Conditions:
Prostate Cancer
Prostate Inflammation
Eligibility:
MALE
18-100 years
Phase:
NA
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 progno...
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 ...
Eligibility Criteria
Inclusion
- Age: Male patients aged 18 years and older.
- Diagnosis: Patients who are suspected of having prostate cancer based on clinical data and standard diagnostic protocols.
- Disease Stage: Patients at any stage of suspected prostate cancer (localized, locally advanced, or metastatic).
- Consent: Ability and willingness to provide written informed consent.
- Clinical Data Availability: Availability of comprehensive clinical data.
- Sample Provision: Willingness to provide blood and/or tissue samples for genetic and inflammatory marker analysis.
Exclusion
- Prior Treatment: Patients who have undergone any prior prostate cancer treatments such as surgery, radiation therapy, or systemic therapies (e.g., hormone therapy, chemotherapy).
- Other Malignancies: Presence of other concurrent malignancies, except for adequately treated basal cell or squamous cell skin cancer.
- Severe Comorbidities: Patients with severe or uncontrolled comorbid conditions that could interfere with study participation or data interpretation (e.g., severe cardiovascular, pulmonary, hepatic, or renal diseases).
- Infection: Active infections or other severe medical conditions that could compromise patient safety or study integrity.
- Non-compliance: Inability to comply with study procedures, follow-up requirements, or any condition that, in the investigator's opinion, could interfere with study participation.
- Medication Use: Use of medications that could interfere with the study results, such as immunosuppressive drugs.
- Additional Considerations:
- Screening: All potential participants will undergo a screening process to verify eligibility criteria.
- Confidentiality: Ensure all patient data is handled in accordance with privacy regulations and ethical guidelines.
- Follow-Up: Participants should be willing to attend regular follow-up visits for ongoing data collection and monitoring of disease progression and treatment response.
- By setting these criteria, the study aims to create a well-defined patient cohort for evaluating the relationship between genetic and inflammatory markers and prostate cancer aggressiveness.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06505356
Start Date
September 1 2024
End Date
August 30 2028
Last Update
March 13 2025
Active Locations (1)
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1
Lithuanian University of Health Sciences
Kaunas, Lithuania