Thin SectionsNCT01054612
Tissue Sectioning by Electro-Dissociation
An observational study of Thin Sections and Fresh Unfixed Tissues, run by University of Arkansas.
Trial summary
Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thin Sections, Fresh Unfixed Tissues, Fresh Unfrozen Tissues
- What is being tested?
- Tissue Sectioning via Electro Erosion Process
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Discarded human tissue obtained immediately following surgical resection
Who may be able to join
- Fresh Tissue
- Unfrozen Tissue
- Unfixed Tissue
Who cannot join
- Unfresh Tissue
- Frozen Tissue
- Fixed Tissue
About this study
Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. Traditional frozen sectioning preserves protein and nucleic acid structure, but the inherent ice artifact precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the limitations of the existing sectioning techniques result from the fact that they rely on mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to cut tissue via an electro erosion process that utilizes focus radio frequency (RF).
- Conditions
- Thin Sections, Fresh Unfixed Tissues, Fresh Unfrozen Tissues
- Being tested
- Tissue Sectioning via Electro Erosion Process
- Keywords
- Histology, Immunohistochemical, Gene Expression, Tissue Sectioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Sectioning via Electro Erosion ProcessOther
Focused RF energy can be used to produce consecutive thin sections of fresh tissue for immunohistochemical and nucleic acids analysis by electro-dissociation without thermal damage, ultimately allowing high resolution reconstruction of gene and protein expression patterns of large tissue specimens in 3D.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2002
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: The study was closed due to the departure of several of the co-investigators.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin SectionsStudies of the same condition, open and under way.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Gal Shafirstein, Ph.D., Principal investigator, UAMS, ACH, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054612
- Sponsor's protocol ID
- IRB 28177
- Other IDs
- NBIB
- Status last verified
- Mar 2015
- First submitted
- 21 Dec 2007
- Last updated
- 4 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sectioning by Electro-Dissociation
- ClinicalTrials.gov ID
- NCT01054612
- Acronym / sponsor ID
- IRB 28177
- Conditions
- Thin Sections, Fresh Unfixed Tissues, Fresh Unfrozen Tissues
- Keywords
- Histology, Immunohistochemical, Gene Expression, Tissue Sectioning
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was closed due to the departure of several of the co-investigators.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- 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.
Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. Traditional frozen sectioning preserves protein and nucleic acid structure, but the inherent ice artifact precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the limitations of the existing sectioning techniques result from the fact that they rely on mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to cut tissue via an electro erosion process that utilizes focus radio frequency (RF).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Discarded human tissue obtained immediately following surgical resection
Key inclusion criteria (3 listed)
- Fresh Tissue
- Unfrozen Tissue
- Unfixed Tissue
Key exclusion criteria (3 listed)
- Unfresh Tissue
- Frozen Tissue
- Fixed Tissue
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 |
|---|---|---|
| Tissue Sectioning via Electro Erosion ProcessFocused RF energy can be used to produce consecutive thin sections of fresh tissue for immunohistochemical and nucleic acids analysis by electro-dissociation without thermal damage, ultimately allowing high resolution reconstruction of gene and protein expression patterns of large tissue specimens in 3D. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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.
Gal Shafirstein, Ph.D. principal investigator
UAMS, ACH, Central Arkansas Veterans Healthcare System
Questions about this trial
What is this clinical trial studying?
An observational study of Thin Sections and Fresh Unfixed Tissues, run by University of Arkansas.
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 3 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: withdrawn, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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.
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 4 Mar 2015.