Characterization of Mechanical Tissue Properties in Patients With Panc

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

Recruiting now.

https://clinicaltrials.gov/ct2/show/NCT03137706

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Purpose
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 Intervention
Colon Carcinoma
Liver and Intrahepatic Bile Duct Carcinoma
Pancreatic Carcinoma
Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Other: Laboratory Procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Intrahepatic Cholangiocarcinoma
U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
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.

Biospecimen Retention: Samples With DNA
Tissue

Estimated Enrollment: 40
Actual Study Start Date: November 14, 2016
Estimated Study Completion Date: February 14, 2019
Estimated Primary Completion Date: February 14, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03137706

Contacts
Contact: Olga Castellanos 310-272-7653 ocastell@usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Shannon Mumenthaler 323-442-2529 smumenth@usc.edu
Principal Investigator: Shannon Mumenthaler
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon Mumenthaler, Ph.D. University of Southern California
More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03137706 History of Changes
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 ( US NIH Grant/Contract Award Number )
Study First Received: April 29, 2017
Last Updated: April 29, 2017
Individual Participant Data
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
Carcinoma, Ductal
Pancreatic Neoplasms
Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 12, 2017