Safety of IntraOperative Cell Salvage in visceral ONcologic surgery
Organizational Data
- DRKS-ID:
- DRKS00033355
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-01-05
- Last update in DRKS:
- 2024-01-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
SIOCSON
URL of the study
No Entry
Brief summary in lay language
Intraoperative Cell Salvage (IOCS) during surgery is routinely used outside of cancer surgery. Retransfusion of processed IOCS-blood is an effective method of treating anemia. IOCS is currently not used in most cases of cancer surgery, as it is unclear whether cancer cells capable of proliferation are still present after processing, which could, for example, form metastases. In this study, wound blood lost during cancer surgery will be collected and processed by a cell salvage machine. It will be investigated in the laboratory whether and how many cancer cells are present in the wound blood before and after processing and to what extent these have the potential to grow, divide and/or form metastases. In this respect, they will also be compared with circulating cancer cells from the patient's blood before and after cancer surgery and with cancer cells from the main tumor. Blood will be drawn from the patients before and after surgery. During the operation, the wound blood that patients lose from the surgical site is aspirated with a special aspirator, collected, purified and analyzed in the laboratory in order to examine it for cancer cells. This blood would normally be disposed of as waste, but we want to use it for our research project instead. Furthermore, the surgeon will provide us with a sample of the main tumor for the research purposes mentioned here. The blood and the tumor sample will be examined in the laboratory.
Brief summary in scientific language
Intraoperative autologous blood cell salvage (IOCS) is a well-established method to collect, wash and re-transfuse patients’ own blood in order to reduce the rate and amount of allogeneic red blood cell transfusion. However, the widespread use of IOCS in cancer surgery is prohibited by an unknown oncological safety profile of the autologous IOCS blood. Based on the current evidence, it is unclear whether any cancer cells possibly remaining in the IOCS blood would have the potential to become clinically significant in case of re-transfusion. In this study, IOCS blood shall be collected and processed during visceral cancer surgery. It shall be analyzed ex-vivo for remaining cancer cells, including their potential for growth, invasion, migration and metastasis. They shall also be compared to circulating tumor cells from cancer patients’ blood before and after cancer surgery, and to cancer cells derived from the primary cancer. The goal of this study is to assess the oncological risk profile of IOCS in visceral cancer surgery ahead of a possible randomized controlled clinical study comparing transfusion of autologous IOCS blood versus conventional allogeneic hemotherapy.
Health condition or problem studied
- Free text:
- visceral cancer
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients with visceral cancer surgery
Endpoints
- Primary outcome:
- Number of cancer cells in collected wound blood before and after cell salvage processing
- Secondary outcome:
- - Number of cancer cells in patient blood before and after cancer surgery - Surface markers of CTCs, cancer cells from IOCS (intraoperative cell salvage) blood and the primarius - Functional properties of CTCs, cancer cells from IOCS blood and the primarius (e.g. viability, migration and invasion assays) - Gene expression of CTCs, tumor cells from IOCS blood and the main cancer
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Heidelberg Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2024-05-01
- Actual study start date:
- No Entry
- Planned study completion date:
- 2026-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - written informed consent by the patient - elective visceral surgical tumor resection with suspected blood loss > 300 ml
Exclusion Criteria
- Infectious viral diseases (e.g. HBV, HCV, HIV, COVID-19)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Dr. Dania FischerIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Dr. Dania FischerIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +496221-56-36166
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Dr. Dania FischerIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +496221-56-36166
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Dr. Dania FischerIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +496221-56-36166
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Heidelberg, Klinik für Anästhesiologie69120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-5626460
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizinische-fakultaet-hd.uni-heidelberg.de/einrichtungen/zentrale-einrichtungen/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-03-04
- Ethics committee number:
- S-130/2023
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-03-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- Frietsch T, Steinbicker AU, Horn A, Metz M, Dietrich G, Weigand MA, Waters JH, Fischer D. Safety of Intraoperative Cell Salvage in Cancer Surgery: An Updated Meta-Analysis of the Current Literature. Transfus Med Hemother. 2022 May 11;49(3):143-157. doi: 10.1159/000524538. PMID: 35813601; PMCID: PMC9210012.
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- 2027
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry