Colon CarcinomaNCT03137706
Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
An observational study of Colon Carcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Pancreatic Carcinoma
- What is being tested?
- Biospecimen Collection, Laboratory Biomarker Analysis and Laboratory Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2016to 19 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis, Laboratory Procedure
- Medical subject headings
- Colonic Neoplasms, Carcinoma, Hepatocellular, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo fresh tumor tissue collection
Laboratory Biomarker AnalysisOther
Correlative studies
Laboratory ProcedureOther
Also called Lab Test, Lab Tests, Laboratory Test, Test
Tissue stiffness and cell viability analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Laboratory Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start14 Nov 2016
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon Mumenthaler, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137706
- Sponsor's protocol ID
- 0S-16-1
- Other IDs
- NCI-2016-01955, 0S-16-1, P30CA014089
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
- ClinicalTrials.gov ID
- NCT03137706
- Acronym / sponsor ID
- 0S-16-1
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (tissue stiffness analysis) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Other: Laboratory ProcedurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery to remove primary tumors in the pancreas, liver, or colon
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo fresh tumor tissue collection | Procedure or surgery | Ancillary-correlative (tissue stiffness analysis) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-correlative (tissue stiffness analysis) |
| Laboratory ProcedureAlso: Lab Test, Lab Tests, Laboratory Test, TestTissue stiffness and cell viability analysis | Other | Ancillary-correlative (tissue stiffness analysis) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Mumenthaler, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Carcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young's modulus (stiffness) on fresh tissue (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.