Clinical trial · Interventional
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
- 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)
RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence. PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| diagnostic lymphadenectomy | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| isosulfan blue | Drug | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| therapeutic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Sensitivity and accuracy of lymphatic mapping in colorectal cancer
- measure
- Overall survival
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of colorectal cancer as detected by proctosigmoidoscopy, flexible endoscopy, or gastrografin/barium enema * No evidence of distant metastases by CT scan of the abdomen and pelvis AND chest x-ray or CT scan of the chest performed within 6 weeks prior to enrollment * Preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration * No discovery of distant metastases intra-operatively PATIENT CHARACTERISTICS: * ECOG performance status (PS) or Zubrod PS equal to 2 * Life expectancy \> 5 years not including the disease/diagnosis of colorectal cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No requirement for emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death including: * Perforated colon * Metabolically significant complete bowel obstruction * Massive GI bleeding * Occult bleeding or early or partial bowel obstruction not requiring emergent surgery allowed * No history of Crohn disease, chronic ulcerative colitis, or familial polyposis * No other malignancy within the past 3 years except for completely resected cervical cancer, skin cancer, or in situ cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * See Patient Characteristics * No concurrent participation in another research protocol * Participation during follow up allowed
References
Publications (0)
Data not yet available