A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
MSK clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood draws
Other interventionPatients 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.
colectomy or hepatectomy
Procedure/SurgeryThree 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.
Fibroscan test
Diagnostic testThis may be done either at a preoperative clinic setting or immediately prior to surgery.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: presumptive Stage II or III colon cancer3 interventions
Group B: Stage IV colon cancer with resectable hepatic metastases3 interventions
Group C: Stage IV colon cancer with unresectable hepatic metastases3 interventions
Group D: Stage I colon cancer, pre-neoplastic or benign colon lesions2 interventions
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov