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

Terminated

• Conditions: Liver and Intrahepatic Bile Duct Carcinoma; Colon Carcinoma; Pancreatic Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Laboratory Procedure

• Registration Number: NCT03137706
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11-14
• Study First Submitted: 2017-04-29
• Study First Submitted QC: 2017-04-29
• Study First Posted: 2017-05-03
• Primary Completion: 2020-10-19
• Study Completion: 2020-10-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (tissue stiffness analysis)	Laboratory Biomarker 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.
Ancillary-correlative (tissue stiffness analysis)	Biospecimen Collection	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.
Ancillary-correlative (tissue stiffness analysis)	Laboratory Procedure	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States