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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at new ways to find colon cancer and predict whether it will spread to organs such as the liver. It uses imaging, blood, and tissue samples. It is for adults having certain surgeries for suspected colon cancer or colon growths.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • As part of your usual care, you are having surgery for suspected colon cancer at any stage. This may be colon, liver, or other belly surgery.
  • You may also qualify if you are having part of your colon removed for growths thought to be noncancerous or able to turn into cancer.
  • Surgery may be open, done through small cuts, or done with help from a robot.

Who can't join

  • Colon or rectal cancer has spread outside the liver, or tissue testing shows a cancer other than colorectal adenocarcinoma—the usual type of colon or rectal cancer.
  • You have not had the required type of CT scan, called a portal venous phase scan, within two months before surgery.
  • You have stage IV colon cancer and are having liver tumors removed, but an active colon tumor remains despite treatment and there is no plan to remove it.
  • You have received experimental colon cancer treatments. Approved targeted drugs do not exclude you. You had another cancer outside the colon within five years, except non-melanoma skin cancer.
  • Before surgery, your colon cancer is known to be MSI-high, meaning it has certain changes in its DNA, or you have a known inherited condition that raises colon cancer risk.
  • You have known liver disease, an INR blood-clotting test result above 2, or a known lack of proteins needed for blood to clot.
  • You are expected to need full-dose blood thinners in the hospital, or your surgeon says your medicines greatly raise bleeding risk after a liver biopsy—a small tissue sample.
  • During surgery, findings make the planned surgery or liver biopsy unsafe, impossible, or not helpful; or your surgeon thinks the research procedures pose more than a small risk.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

NJ

NY