NCT06505356Enrolling by invitation
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 4 Jun 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Edgaras Burzinskis
- Diseases
- Prostate cancer
- NCT number
- NCT06505356
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 1 Sept 2024 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Medication Use: Use of medications that could interfere with the study results, such as immunosuppressive drugs.
- Additional Considerations:
Other illness
- 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.
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lithuanian University of Health Sciences Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.