NCT00291122

Brief Summary

To assess the quantitative real time PCR results results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors of indicators of response to celecoxib.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Typical duration 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

January 1, 2003

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

First QC Date

February 10, 2006

Last Update Submit

September 15, 2008

Conditions

Breast Cancer

Keywords

breast atypiabreast epithelial hyperplasiaki-67RTPCRmicrodissection

Interventions

celecoxib 400 mg BIDDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with a recent diagnosis of T1 or T2 noninvasive breast cancer by large core needle or excisional biopsy
  • confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post diagnostic analyses to perform research assessments
  • reexcision planned within 10 days to 6 weeks from study start

You may not qualify if:

  • no hormone replacement therapy within 90 days prior to biopsy
  • no history of asthma, allergy ASA, NSAIDS, celecoxib of other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study
  • no celecoxib or rofecoxib use within one month of biopsy
  • no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
  • no current anticoagulants
  • no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
  • no aromatase inhibitor in the six months prior to participation
  • no concomitant lithium
  • no known significant bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CelecoxibBID protein, human

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Carol J Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

January 1, 2003

Study Completion

December 1, 2005

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

US(1)