Clareo Health | Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lindis Bloodcare GmbH
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Intraoperative blood salvage (IBS)-eligible according to the Investigator
Patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being EpCAM-positive (\>92%) OR kidney carcinoma or liver carcinoma.
For patients with cancer types with a high likelihood of being EpCAM-positive (\>92%): if a tumor tissue sample is available and has been EpCAM tested or EpCAM-testing can be done within 5 days of signing the informed consent form (ICF): results of EpCAM typing should be positive.
For patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested EpCAM-positive prior to surgery.
Scheduled for surgery to remove tumor.
The Investigator expects that at least 400 mL full blood can be collected during the tumor surgery.
An American Society of Anesthesiologists (ASA) Classification of ≤3.
You may not be if
Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
Lymphocytopenia (count \<1.0 x 109 /L lymphocytes).
Cancer different from indicated types, especially typically EpCAM-negative tumor types.
Sepsis occurring during surgery.
Cirrhosis of the liver with a Child-Pugh score of C.
A thrombocyte count of \<30.000/µL.
Allergies and/or contraindications against Catumaxomab or any of the components or ingredients used in the IBS procedure (e.g., leukocyte depletion filter \[LDF\], diluent, buffer solution or anticoagulants).
Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.
