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

Sponsor
University of Southern California (Other)
Overall Status
Terminated
CT.gov ID
NCT03137706
Collaborator
National Cancer Institute (NCI) (NIH)
8
Enrollment
1
Location
47.1
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Laboratory Procedure

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.
SECONDARY OBJECTIVES:
  1. 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:
  1. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
Actual Study Start Date :
Nov 14, 2016
Actual Primary Completion Date :
Oct 19, 2020
Actual Study Completion Date :
Oct 19, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Young's modulus (stiffness) on fresh tissue [Up to 15 months]

      A portable optical fiber polarimetric sensor device to measure the Young's modulus in tissue samples will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Shannon Mumenthaler, Ph.D., University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03137706
    Other Study ID Numbers:
    • 0S-16-1
    • NCI-2016-01955
    • 0S-16-1
    • P30CA014089
    First Posted:
    May 3, 2017
    Last Update Posted:
    Apr 5, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Pancreatic Neoplasms
    Carcinoma, Ductal

    Study Results

    No Results Posted as of Apr 5, 2021