Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT06505356
Eligibility Criteria:
Inclusion Criteria:
1. Age: Male patients aged 18 years and older.
2. Diagnosis: Patients who are suspected of having prostate cancer based on clinical data and standard diagnostic protocols.
3. Disease Stage: Patients at any stage of suspected prostate cancer (localized, locally advanced, or metastatic).
4. Consent: Ability and willingness to provide written informed consent.
5. Clinical Data Availability: Availability of comprehensive clinical data.
6. Sample Provision: Willingness to provide blood and/or tissue samples for genetic and inflammatory marker analysis.
Exclusion Criteria:
1. Prior Treatment: Patients who have undergone any prior prostate cancer treatments such as surgery, radiation therapy, or systemic therapies (e.g., hormone therapy, chemotherapy).
2. Other Malignancies: Presence of other concurrent malignancies, except for adequately treated basal cell or squamous cell skin cancer.
3. 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).
4. Infection: Active infections or other severe medical conditions that could compromise patient safety or study integrity.
5. 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.
6. 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06505356
Study Brief:
Protocol Section:
NCT06505356