Clinical trial · Observational
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
NCT02861430CI-TRIAL-00085780UNMASKcompletedClinicalTrials.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)
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node | — | UNRESOLVED | — |
| Sentinel Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunochemistry and molecular biology on sentinel lymph node specimen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- interventionNames
- Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen
Primary outcomes (1)
- measure
- Concordance between immunochemistry and molecular biology
- timeFrame
- 1 month
- description
- The primary outcome is the rate of concordance between the number of positive sentinel lymph nodes detected by immunochemistry using an anti-cytokeratin antibody (KL1) and molecular biology targeting CK20 on tumoral RNA after RT-PCR. The rate of positivity of the sentinel lymph nodes will be then compared to the standard technique using HES coloration used in routine pathological examination. Only the result using the routine examination will be used to decide whether the patient should benefit from an adjuvant chemotherapy.
Secondary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Colectomy for Non metastatic colon cancer Exclusion Criteria: * Tumor T4 * No medical insurance * Pregnant woman * Psychiatric disorders
References
Publications (0)
Data not yet available
No reference posted for this study.