Clinical trial · Observational
Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement
Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
- 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)
This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival. Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.
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 |
|---|---|---|---|
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ctDNA/cfDNA levels in relation to colorectal stent placement
- timeFrame
- 2 years
- description
- Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement.
Secondary outcomes (2)
- measure
- Immunological response
- timeFrame
- 2 years
- description
- Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed
- measure
- Metastatic ability of the cancer cells
- timeFrame
- 2 years
- description
- Cell adhesion assay, proliferation and migration will be performed on serum.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between the ages of 18 to 95 years * Patients with acute malignant obstruction in the colon. * ASA class I-III (Classification of the American Society of Anesthesiology) * Signed informed consent Exclusion Criteria: * Known immune-defects * Withdrawal of informed consent * Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement. * Surgery within 24 hours after stent-placement * Known inflammatory bowel disease
References
Publications (0)
Data not yet available