A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-28

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colon Cancer Liver Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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presumptive Stage II or III colon cancer

blood draws

Intervention Type OTHER

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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

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

Stage IV colon cancer with resectable hepatic metastases

blood draws

Intervention Type OTHER

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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

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

Stage IV colon cancer with unresectable hepatic metastases

blood draws

Intervention Type OTHER

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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

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

Stage I colon cancer, pre-neoplastic or benign colon lesions

blood draws

Intervention Type OTHER

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Fibroscan test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No