Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence

This study has been withdrawn prior to enrollment.
(Trial terminated - Nanoscale Company out of business)
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01707758
First received: October 12, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Biospecimen Retention:   Samples Without DNA

Approximately 1 tablespoon of blood will be collected from each subject.


Enrollment: 0
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
pancreatic cancer
This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

Inclusion Criteria for Pancreatic Cancer Patients:

  • 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

Inclusion Criteria for Healthy Subjects:

  • Subjects will have no prior history of any cancer

Exclusion Criteria:

Exclusion Criteria for Pancreatic Cancer Patients

  • Any prior treatment for pancreatic cancer
  • Poorly controlled diabetes

Exclusion Criteria for Healthy Subjects

  • Poorly controlled diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707758

Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Stephen Williamson, MD University of Kansas Medical Center Cancer Center
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01707758     History of Changes
Other Study ID Numbers: 13421
Study First Received: October 12, 2012
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
pancreatic cancer
nanoparticle
proteases
cell survival
tumor progression
angiogenesis
tissue remodeling/invasion

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014