Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association… (NCT06505356) | Clinical Trial Compass
By InvitationNot Applicable
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
Lithuania400 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Inflammatory markers' effect on prostate cancer aggressiveness
Timeframe: 2 weeks
2
Genetic polymorphism markers' effect on prostate cancer aggressiveness
. 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.