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
1 other identifier
observational
51
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2017
CompletedFirst Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
December 2, 2025
December 1, 2025
8.9 years
February 8, 2018
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
successful isolation of exosomes
defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.
1 year
Study Arms (4)
presumptive Stage II or III colon cancer
Stage IV colon cancer with resectable hepatic metastases
Stage IV colon cancer with unresectable hepatic metastases
Stage I colon cancer, pre-neoplastic or benign colon lesions
Interventions
Patients will have 10 mL of peripheral venous blood drawn immediately prior to surgery, in the post anesthesia care unit (PACU), and at the first postoperative clinic visit for a total of 30 mL.
Three small pieces of otherwise "normal-appearing" liver of 0.5-1 cm3 collected intraoperatively from patients in all four groups (including Group D). Because liver biopsy is less frequently performed during operations for benign colon lesions or Stage I-III colon cancers, this single aspect of the protocol can be made optional at the discretion of the surgical attending or the patient, however bloods and tissue from pathology will still be collected.
This may be done either at a preoperative clinic setting or immediately prior to surgery.
Eligibility Criteria
MSK clinic
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
Biospecimen
blood and tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D'Angelica
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2018
First Posted
February 14, 2018
Study Start
November 28, 2017
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12