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A Screening Study of Patients with Breast Cancer to Evaluate Urine PGE-M Levels and COX-2 Expression in Tumor Samples

Researcher
Ella Looper The Methodist Hospital Research Institute, Houston, Texas
Study abstract

This study will collect the PGE-M and COX-2 IHC levels in subjects with breast cancer to establish whether urinary PGE-M can be used as a surrogate marker for increased COX-2 expression.

AIMS:
1. The primary objective is to determine the level of PGE-M in the urine of breast cancer patients.
2. The secondary objective is to correlate PGE-M expression in urine expression of COX-2 through IHC in tumor tissue.
3. The third objective is to test the difference in urinary PGE-M level between the patients with tumor and patients without tumor.

Study review

This study will collect the PGE-M and COX-2 IHC levels in subjects with breast cancer to establish whether urinary PGE-M can be used as a surrogate marker for increased COX-2 expression.

AIMS:
1. The primary objective is to determine the level of PGE-M in the urine of breast cancer patients.
2. The secondary objective is to correlate PGE-M expression in urine expression of COX-2 through IHC in tumor tissue.
3. The third objective is to test the difference in urinary PGE-M level between the patients with tumor and patients without tumor.

To pursue above mentioned hypothesis and aims, we plan to study female patients ≥18 years of age with either metastatic or early stage breast cancer with intact tumor and patients who have been recently diagnosed with breast cancer and are currently tumor-free.

One urine sample and one tumor sample from tumor paraffin blocks (5 slides minimum) will be taken from approximately 340 breast cancer patients according to the following scheme:
80 Her2/neu positive by IHC or FISH positive (any ER/PR) patients
80 ER+ and/or PR+ patients/Her2/neu negative by IHC or FISH negative
80 triple negative patients (Her2/neu negative by IHC or FISH negative, ER-, PR)
100 recently diagnosed patients who have had surgical resection and have no tumor present to serve as negative controls, no specific Her2/neu or ER/PR receptor status is required from this group of patients.