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

Conditions

• Colon Cancer
• Liver Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• blood draws — 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 — 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 — DIAGNOSTIC_TEST
  This may be done either at a preoperative clinic setting or immediately prior to surgery.

Study Details

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.

Key Dates

First listed

Feb 14, 2018

Start date

Nov 28, 2017

Status verified

Oct 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: presumptive Stage II or III colon cancer
• Arm: Stage IV colon cancer with resectable hepatic metastases
• Arm: Stage IV colon cancer with unresectable hepatic metastases
• Arm: Stage I colon cancer, pre-neoplastic or benign colon lesions

Primary Outcome Measure

successful isolation of exosomes [ Time Frame: 1 year ]

Central Contacts

• Michael D'Angelica, MD
  212-639-3226
  [email protected]
• Martin Wieser, MD
  212-639-6698

Locations (4)

Find similar trials in Basking Ridge, NJ

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