NCT01707758

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

October 12, 2012

Last Update Submit

May 15, 2013

Conditions

Keywords

pancreatic cancernanoparticleproteasescell survivaltumor progressionangiogenesistissue remodeling/invasion

Study Arms (1)

pancreatic cancer

This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Any prior treatment for pancreatic cancer
  • Poorly controlled diabetes
  • Poorly controlled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pancreatic NeoplasmsDisease Progression

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen Williamson, MD

    University of Kansas Medical Center Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 16, 2013

Record last verified: 2013-05