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Sponsored by: |
University of Kansas |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00291122 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: celecoxib 400 mg BID |
Phase I |
Study Type: | Observational |
Official Title: | Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib |
Estimated Enrollment: | 100 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2005 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Carol J Fabian, MD | University of Kansas |
Study ID Numbers: | 9380 |
Study First Received: | February 10, 2006 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00291122 |
Health Authority: | United States: Institutional Review Board |
breast atypia breast epithelial hyperplasia ki-67 RTPCR microdissection |
Hyperplasia Celecoxib Skin Diseases |
Formaldehyde Breast Neoplasms Breast Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |