Clinical trial · Observational
A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study
NCT03432806CI-TRIAL-00098221active not recruitingClinicalTrials.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)
The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.
Conditions
Conditions (2)
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 |
| Liver Tumors | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood draws | Other | — | UNRESOLVED |
| colectomy or hepatectomy | Procedure | — | UNRESOLVED |
| Fibroscan test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- presumptive Stage II or III colon cancer
- interventionNames
- Other: blood draws
- Procedure: colectomy or hepatectomy
- Diagnostic Test: Fibroscan test
- label
- Stage IV colon cancer with resectable hepatic metastases
- interventionNames
- Other: blood draws
- Procedure: colectomy or hepatectomy
- Diagnostic Test: Fibroscan test
- label
- Stage IV colon cancer with unresectable hepatic metastases
- interventionNames
- Other: blood draws
- Procedure: colectomy or hepatectomy
- Diagnostic Test: Fibroscan test
- label
- Stage I colon cancer, pre-neoplastic or benign colon lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria: * Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP) * Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas) * Open, laparoscopic, or robotic resections * ≥18 years old Exclusion Criteria: * Extrahepatic CRC metastasis * No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma. * Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy. * Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion. * History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer) * Colon cancer with microsatellite instability (MSI-high) if known preoperatively * Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) * Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc) * INR \>2 or known clotting factor deficiency * Anticipated need for full anticoagulation during hospitalization * Receipt of medications that increase significantly the risk of bleeding after liver biopsy (at the surgeon"s discretion) * Intraoperative discovery of pathology that precludes the planned surgical resection or liver biopsy, or makes resection futile (such as peritoneal carcinomatosis or other extrahepatic metastatic disease) * Operating surgeon deems research interventions to be more than a minimal risk for the patient
References
Publications (0)
Data not yet available
No reference posted for this study.