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Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib


To assess the quantitative real time PCR results of oligonucleotide probes for a number of
gene transcription products that may be useful as predictors or indicators of response to
celecoxib, the feasibility of performing six different molecular assays by qRTPCR on
formalin fixed paraffin embedded tissue obtained from breast cancer core biopsies and breast
cancer reexcision patients, to assess change in Ki-67, PCNA, and several other markers by
qRTPCR, correlate change in expression of Ki-67, PCNA, CAX-2, and bcl-2, measured by
immunohistochemistry to change measured by qRTPCR, and to determine the reliability of the
qRTPCR and immunohistochemical assays by performed selected assays on the same tissue in two
different institutions


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9380

NCT ID:

NCT00291122

Start Date:

January 2003

Completion Date:

December 2005

Related Keywords:

  • Breast Cancer
  • breast atypia
  • breast epithelial hyperplasia
  • ki-67
  • RTPCR
  • microdissection
  • Breast Neoplasms

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353