Recruiting

Colon Cancer Diagnosis

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03432806

Conditions

Colon Cancer

Liver Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood draws

colectomy or hepatectomy

Fibroscan test

Study Details

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.

Conditions

Colon Cancer

Liver Tumors

Study ID

NCT03432806

Start date

Nov 28, 2017

Status verified date

Oct, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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

blood draws

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.

colectomy or hepatectomy

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.

Fibroscan test

This may be done either at a preoperative clinic setting or immediately prior to surgery.

Primary outcome measure

  • successful isolation of exosomes [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Michael D'Angelica, MD

212-639-3226dangelim@mskcc.org

Martin Wieser, MD

212-639-6698

Locations

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Michael D'Angelica, MD

212-639-3226

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Michael D'Angelica, MD

212-639-3226

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Michael D'Angelica, MD

212-639-3226

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Michael D'Angelica, MD

212-639-3226

Martin Weiser, MD

212-639-6698

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Tissue samples
  • 17-594

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.