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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Colon Carcinoma
• Liver and Intrahepatic Bile Duct Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms

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