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 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT05449366
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmed diagnosis of malignant peritoneal mesothelioma
* Patients that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC)
* Age ≥ 18 years old
* Written informed consent according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and national/local regulations
* Patients must be ambulatory, i.e. World Health Organization-Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0 or 1
* Ability to return to the Erasmus Medical Center for adequate follow-up as required by this protocol
* Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements; absolute neutrophil count \>1.5 \* 10\^9/l, platelet count \>100\*10\^9/l and Hemoglobin \>6.0mmol /l. Patients must have a Bilirubin \<1½ x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x ULN
Exclusion Criteria:
* Extra-abdominal disease/metastatic disease established by preoperative CT-scan of thorax-abdomen and/or PET-scan. Imaging not older than two months at time of surgery
* Medical or psychological impediment to probable compliance with the protocol
* Serious concomitant disease or active infections
* History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis
* Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study
* Pregnant or lactating women; for all women of child-bearing potential a negative urine pregnancy test will be required as well as the willingness to use adequate contraception during the study until 4 weeks after finishing treatment
* Absence of assurance of compliance with the protocol
* An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05449366
Study Brief:
Protocol Section:
NCT05449366