Pancreatic CancerNCT01707758
Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence
An observational study of Pancreatic Cancer, run by University of Kansas.
Trial summary
The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from the University of Kansas Cancer Center prior to any treatment for their pancreatic cancer. Final histology and staging will be recorded and correlated with protease concnentration. Healthy subjects will be recruited from the University of Kansas and Kansas State community.
Who may be able to join
- Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
- Patients will have had no prior treatment or surgery
- Subjects will have no prior history of any cancer
Who cannot join
- Any prior treatment for pancreatic cancer
- Poorly controlled diabetes
- Poorly controlled diabetes
About this study
The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.
Read the detailed description
The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, nanoparticle, proteases, cell survival, tumor progression, angiogenesis, tissue remodeling/invasion
- Medical subject headings
- Pancreatic Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cancer | This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Trial terminated - Nanoscale Company out of business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Williamson, MD, Principal investigator, University of Kansas Medical Center Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707758
- Sponsor's protocol ID
- 13421
- Status last verified
- May 2013
- First submitted
- 12 Oct 2012
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence
- ClinicalTrials.gov ID
- NCT01707758
- Acronym / sponsor ID
- 13421
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, nanoparticle, proteases, cell survival, tumor progression, angiogenesis, tissue remodeling/invasion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Trial terminated - Nanoscale Company out of business
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Oct 2012 (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.
The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.
Detailed description
The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic cancer | – | –This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the University of Kansas Cancer Center prior to any treatment for their pancreatic cancer. Final histology and staging will be recorded and correlated with protease concnentration. Healthy subjects will be recruited from the University of Kansas and Kansas State community.
Key inclusion criteria (3 listed)
- Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
- Patients will have had no prior treatment or surgery
- Subjects will have no prior history of any cancer
Key exclusion criteria (3 listed)
- Any prior treatment for pancreatic cancer
- Poorly controlled diabetes
- Poorly controlled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 16 May 2013.
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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.
Stephen Williamson, MD principal investigator
University of Kansas Medical Center Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by University of Kansas.
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 16 May 2013. 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 16 May 2013.