NCT00851955

Brief Summary

The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in PC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.6 years

First QC Date

February 25, 2009

Last Update Submit

January 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    One year

Secondary Outcomes (1)

  • For pancreatic patients from whom tissue samples will be available, we will examine the association between presence/absence of each marker in the tissue versus the marker level in blood and in pancreatic juice.

    One year

Study Arms (3)

1. Normal pancreas patients

Patients with no documented clinical history of pancreatic diseases supported by at least 1 negative imaging test (EUS, CT scan or MRI).

2. Chronic pancreatitis patients

Patients with documented diagnosis of moderate to advanced chronic pancreatitis supported by at least 1 positive imaging test (EUS,CT scan or MRI).

3. Pancreatic cancer patients

Patients with documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care

You may qualify if:

  • Normal subjects - No documented clinical history of pancreatic diseases supported by at least 1 negative imaging test. (EUS, Ct scan or MRI)
  • Chronic pancreatitis - Documented diagnosis of moderate to advanced chronic supported bpancreatitisy at least 1 positive imaging test. (EUS, Ct scan or MRI)
  • Pancreatic Cancer - Documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatic Neoplasms

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Massimo Raimondo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

November 1, 2011

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations