Clinical trial · Observational
Immunological and Oxidative Stress Response in Relation to Abdominal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to characterize the systemic stress response (SSR) induced in patients undergoing colorectal cancer (CRC) surgery. The project is a clinical prospective study. Blood samples will be collected from 30 patients on the day before CRC-surgery, and 1, 2, 3 and 10 days after surgery. A specimen from the resected tumor tissue will also be collected and sent for immunohistochemical analysis. Whole blood gene expression profiling will be performed to gain knowledge of the genetic changes in immunological, inflammatory and oxidative stress-related factors initiated by surgery. Peripheral immunological cells, proteins and cytokines will be analysed by FLOW and ELISA methods, and the functional capacity of NK-cells will also be defined for each time point. Furthermore, tumor tissue will be analyzed for invasion of immunological cells. At each time point, the patients will be asked to fill out a validated patient reported outcome measure with questions concerning clinical outcome parameters related to recovery after CRC-surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Oxidative and immunological gene-expression before and after laparoscopic surgery for colon cancer using whole blood gene expression profiling from blood samples
- timeFrame
- 1 year
- description
- The most significantly differentially expressed probe sets will be chosen for further analysis. Examples of exact genes will be genes encoding for TNFα, IL-1b, IL-2, IL-6, IL-10, VEGF, TGFβ and HLA-G. Within oxidative and antioxidative genes, special emphasis will be taken in FoxO3, TP53 and ATM.
Secondary outcomes (2)
- measure
- Specific immune modulating proteins in blood before and after laparoscopic surgery for colon cancer, using flow cytometry and NK-cell isolation from blood samples
- timeFrame
- 1 year
- description
- TNFα, IL-1b, IL-2, IL-6, IL-10, VEGF, TGFβ and HLA-G, the functional activity of NK-cells, and the fractions and absolute numbers of specific sub-populations of CD3+CD4+, CD3+CD8+, FoxP3+ / CD4+CD25+CD127 /dim regulatory T cells, CD4+HLA-G+ regulatory T cells, myeloid-derived suppressor cells and NK subsets will be identified before and after surgery.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients between 18 to 75 years of age 2. Patients diagnosed with colon cancer (UICC stadium II-III) and scheduled for laparoscopic hemicolectomy. 3. ASA class I-III (Classification of the American Society of Anesthesiology) 4. Signed informed consent Exclusion Criteria: 1. Known immune-defects 2. Withdrawal of informed consent
References
Publications (0)
Data not yet available