NCT01353950

Brief Summary

The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

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

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

May 12, 2011

Last Update Submit

April 4, 2017

Conditions

Cystic Fibrosis

Keywords

Costimulatory moleculesCystic FibrosisBiomarkers

Study Arms (1)

Adult Cystic Fibrosis Patients

Adults with Cystic Fibrosis will be followed longitudinally for 2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with Cystic Fibrosis

You may qualify if:

  • Willingness to participate

You may not qualify if:

  • Presence of HIV
  • Presence of Lymphoma/Leukemia
  • Presence of Lung or other solid organ Transplant
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon health and Sciences University

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Serum, urine

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

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

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

US(1)