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:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT06152367
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed melanoma of the skin: Breslow, Clark, histological type. Location of the primary, clinical, or pathological regional status.
* Complete staging demonstrating the presence of distant metastases, either visceral or in soft tissues or bone tissue: Brain, Lung, Abdomen, and Pelvis CT and bone scintigraphy.
* Objectively measurable disease by clinical or radiological means
* Karnofsky's Performance Status is more significant than 70%
* Life expectancy greater than three months
* Patients over 18 years old
* Informed consent from the patient to participate in the protocol
Exclusion Criteria:
* Age greater than or equal to 65 years
* Ongoing active infections, including viral immunodeficiency
* Previous chemotherapy within less than two months
* Concomitant malignant tumors (e.g., Chronic Lymphocytic Leukemia, etc.)
* Uncontrolled concomitant diseases (Hypertension, unstable Diabetes mellitus, renal diseases requiring dialysis)
* Situations or conditions requiring urgent surgical intervention, such as intestinal obstruction due to metastasis
* Pregnancy or lactation
* Concurrent participation in other therapeutic research protocols
* Any condition that compromises the objectives of this study.
Removal Criteria from the Study:
* By the patient's decision to discontinue the study.
* Intolerable adverse reactions, according to WHO Criteria Grading Toxicities
* Intercurrent illness that may compromise the patient's life or interfere with the treatment study evaluation
* Requirements for concomitant medication that may interfere with study results.
* Failure to complete the study entirely
* Failure to follow up on the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06152367
Study Brief:
Protocol Section:
NCT06152367