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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00918593
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18.
* Histological proven cancer, any histology.
* Progressive and/or metastatic disease.
* One or more ulcerating cutaneous metastases.
* Patient in need of palliation of the ulcerating metastases.
* Lesion to be treated between 1 cm - 5 cm in diameter.
* Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy.
* WHO performance ≤ 2.
* Life expectancy of at least 3 months.
* Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.
* Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
* Written informed consent must be obtained according to the local Ethics committee requirements.
Exclusion Criteria:
* Previous electrochemotherapy or radiotherapy in the area to be treated
* Acute lung infection
* Previous bleomycin treatment exceeding 200.000 Units/m2.
* Known hypersensitivity to any of the components of the treatment.
* Known hypersensitivity to any of the components used in the planned anaesthesia.
* Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
* Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
* Creatinine measurements over 150 micromolar will require Crohm-EDTA clearance. Crohm-EDTA below 48 ml/minute
* Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00918593
Study Brief:
Protocol Section:
NCT00918593