NCT06789224Completed
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 10 Jan 2025
- Start date
- 15 Feb 2022
- Primary completion date
- 25 Nov 2023
- Lead sponsor
- Lindis Bloodcare GmbH
- Diseases
- Prostate cancer, Kidney cancer, Bladder cancer, Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT06789224
What you commit to
- Study type: Interventional
- Participants enrolled: 136
- From 15 Feb 2022 to the primary completion date, 25 Nov 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
- Sepsis occurring during surgery.
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.
Other illness
- Cancer different from indicated types, especially typically EpCAM-negative tumor types.
Lab values
- Lymphocytopenia (count \<1.0 x 109 /L lymphocytes).
- 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).
Other
- Cirrhosis of the liver with a Child-Pugh score of C.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kliniken der Stadt Köln gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Klinikum Traunstein Coordinator of this site? Confirm its status | Traunstein | Germany | Unknown status |
| Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.