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NCT03137706 Clinical Trial

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

Pancreatic Carcinoma Clinical Trial

Official title:
Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03137706
Other study ID # 0S-16-1
Secondary ID NCI-2016-019550S
Status Terminated
Phase
First received
Last updated
Start date November 14, 2016
Est. completion date October 19, 2020

Study information
Verified date April 2021
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date October 19, 2020
Est. primary completion date October 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo fresh tumor tissue collection
Other:
• Laboratory Biomarker Analysis
Correlative studies
• Laboratory Procedure
Tissue stiffness and cell viability analysis

Locations
Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Young's modulus (stiffness) on fresh tissue A portable optical fiber polarimetric sensor device to measure the Young's modulus in tissue samples will be used. Up to 15 months
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