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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

Tracking Information
First Submitted Date April 29, 2017
First Posted Date May 3, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date November 14, 2016
Estimated Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03137706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
Official Title Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue
Sampling Method Non-Probability Sample
Study Population Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon
Condition
  • Colon Carcinoma
  • Liver and Intrahepatic Bile Duct Carcinoma
  • Pancreatic Carcinoma
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Laboratory Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 29, 2017)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 14, 2021
Estimated Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Olga Castellanos 310-272-7653 ocastell@usc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03137706
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Southern California
Study Sponsor University of Southern California
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon Mumenthaler, Ph.D. University of Southern California
PRS Account University of Southern California
Verification Date May 2019