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Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer

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ClinicalTrials.gov Identifier: NCT03137706
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This pilot research trial studies characterization of mechanical tissue properties in patients with pancreatic, liver, or colon cancer. Mechanical properties and stiffness of the cancerous tissue may be correlated with the standard pathology report that describes the stage of the disease.

Condition or disease Intervention/treatment
Colon Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Pancreatic Carcinoma Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Laboratory Procedure

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.

SECONDARY OBJECTIVES:

I. To describe the inter- and intra-tumor heterogeneity of tissue stiffness. II. To determine if the measurements made by the optical polarimeter device are non-destructive.

TERTIARY OBJECTIVES:

I. Perform multi-variable cross-correlation statistical analysis to determine relationships between: tissue stiffness characteristics, molecular level signatures, and cellular level properties, and if numbers permit, response to treatment.

OUTLINE:

Patients undergo fresh tumor tissue collection at the time of surgery. The fresh tumor tissue samples are analyzed for tissue stiffness measurements using an optical polarimeter device and cell viability using an automated cell counter.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
Actual Study Start Date : November 14, 2016
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : February 14, 2021


Group/Cohort Intervention/treatment
Ancillary-correlative (tissue stiffness analysis)
Patients undergo fresh tumor tissue collection at the time of surgery. The fresh tumor tissue samples are analyzed for tissue stiffness measurements using optical polarimeter device and cell viability using automated cell counter.
Procedure: Biospecimen Collection
Undergo fresh tumor tissue collection

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Laboratory Procedure
Tissue stiffness and cell viability analysis
Other Names:
  • Lab Test
  • Lab Tests
  • Laboratory Test
  • Test
  • Tests




Primary Outcome Measures :
  1. Young's modulus (stiffness) on fresh tissue [ Time Frame: Up to 15 months ]
    A portable optical fiber polarimetric sensor device to measure the Young's modulus in tissue samples will be used.


Biospecimen Retention:   Samples With DNA
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
Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon
Criteria

Inclusion Criteria:

  • Scheduled for surgery to remove primary tumors in the pancreas, liver or colon and have not undergone any prior treatment
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Pregnant women will not be consented
  • Patients that are unable to consent for surgery
  • Primary liver tumors with cirrhosis will be excluded from this study

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): NCT03137706


Contacts
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Contact: Olga Castellanos 310-272-7653 ocastell@usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Shannon Mumenthaler    323-442-2529    smumenth@usc.edu   
Principal Investigator: Shannon Mumenthaler         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Shannon Mumenthaler, Ph.D. University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03137706     History of Changes
Other Study ID Numbers: 0S-16-1
NCI-2016-01955 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-16-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary