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Trial record 13 of 179 for:    colon cancer | ( Map: New Jersey, United States )

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

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ClinicalTrials.gov Identifier: NCT03432806
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Colon Cancer Liver Tumors Other: blood draws Procedure: colectomy or hepatectomy Diagnostic Test: Fibroscan test

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Group/Cohort Intervention/treatment
presumptive Stage II or III colon cancer Other: blood draws
Three peripheral venous blood draws (10 mL per draw): in the operating room prior to incision, upon completion of the surgical procedure (within 6hours), and first postoperative clinic visit.

Procedure: 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).

Diagnostic Test: Fibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.

Stage IV colon cancer with resectable hepatic metastases Other: blood draws
Three peripheral venous blood draws (10 mL per draw): in the operating room prior to incision, upon completion of the surgical procedure (within 6hours), and first postoperative clinic visit.

Procedure: 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).

Diagnostic Test: Fibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.

Stage IV colon cancer with unresectable hepatic metastases Other: blood draws
Three peripheral venous blood draws (10 mL per draw): in the operating room prior to incision, upon completion of the surgical procedure (within 6hours), and first postoperative clinic visit.

Procedure: 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).

Diagnostic Test: Fibroscan 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 Other: blood draws
Three peripheral venous blood draws (10 mL per draw): in the operating room prior to incision, upon completion of the surgical procedure (within 6hours), and first postoperative clinic visit.

Procedure: 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).




Primary Outcome Measures :
  1. successful isolation of exosomes [ Time Frame: 1 year ]
    defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.


Biospecimen Retention:   Samples Without DNA
blood and tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSK clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432806


Contacts
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Contact: Michael D'Angelica, MD 212-639-3226 dangelim@mskcc.org
Contact: Martin Wieser, MD 212-639-6698

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael D'Angelica, MD    212-639-3226      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael D'Angelica, MD    212-639-3226      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael D'Angelica, MD    212-639-3226      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael D'Angelica, MD    212-639-3226      
Contact: Martin Weiser, MD    212-639-6698      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Michael D'Angelica Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03432806     History of Changes
Other Study ID Numbers: 17-594
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Tissue samples
17-594

Additional relevant MeSH terms:
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Colonic Neoplasms
Liver Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Liver Diseases