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

NCT03137706 | Terminated DMC

• 3 other identifiers: 0S-16-1NCI-2016-01955P30CA014089
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Other: Laboratory Biomarker Analysis; Other: Laboratory Procedure

Interventions

Biospecimen Collection PROCEDURE

Undergo fresh tumor tissue collection

Ancillary-correlative (tissue stiffness analysis)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (tissue stiffness analysis)

Laboratory Procedure OTHER

Tissue stiffness and cell viability analysis

Also known as: Lab Test, Lab Tests, Laboratory Test, Test, Tests

Ancillary-correlative (tissue stiffness analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Colonic Neoplasms; Carcinoma, Hepatocellular; Pancreatic Neoplasms

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Shannon Mumenthaler, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2017
• First Posted: May 3, 2017
• Study Start: November 14, 2016
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (1)