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2016-11-14
2020-10-19
2020-10-19
8
NCT03137706
University of Southern California
University of Southern California
OBSERVATIONAL
Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-29 | N/A | 2021-04-01 |
2017-04-29 | N/A | 2021-04-05 |
2017-05-03 | N/A | 2021-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
