Clinical trial · Observational
Intraoperative Flow Cytometry In Colorectal Cancer
Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry
NCT05261542CI-TRIAL-00056807completedClinicalTrials.gov clinicaltrialsProvenance
- 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 was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- normal colorectal epithelium
- description
- Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient
- interventionNames
- Diagnostic Test: flow cytometry
- label
- cancer colorectal epithelium
- description
- Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient
- interventionNames
- Diagnostic Test: flow cytometry
Primary outcomes (1)
- measure
- Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.
- timeFrame
- 2017-2021
- description
- Samples from cancer and normal colon epithelium are prospectively collected intraoperatively and assessed with intraoperative Flow Cytometry. Following comparative DNA content and phenotypic analysis, the receiver operating characteristic (ROC) curve analysis is used to evaluate the performance of intraoperative Flow Cytometry to distinguish between normal and cancer tissue. The optimal cut-off value is determined to delineate the status of tumor tissue, resulting in the highest sensitivity and specificity and hence the optimal accuracy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: biopsy proven colorectal cancer signed informed consent for participation Exclusion Criteria:
References
Publications (0)
Data not yet available
No reference posted for this study.