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Spots Global Cancer Trial Database for Relationship of Ochratoxin A to Upper Urologic Cancers

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Trial Identification

Brief Title: Relationship of Ochratoxin A to Upper Urologic Cancers

Official Title: The Relationship of Ochratoxin A to Upper Tract TCC Malignancies, Testicular Cancer, and Renal Cell Cancer

Study ID: NCT00216801

Interventions

Study Description

Brief Summary: This pilot study will explore the relationship of Ochratoxin A (OTA) levels in patients with upper tract transitional cell (TCC), renal cell, and testicular cancers by measuring levels of OTA in serum and tumor samples. Dietary exposure will also be analyzed.

Detailed Description: Ochratoxin A (OTA, a ubiquitous mycotoxin) is a common food contaminant that enters the food chain from plants such as cereals. OTA can be inhaled or ingested and livestock and humans feeding on OTA contaminated food have been found to have detectable levels of this chemical in their sera, liver, and kidneys. There is risk for occupational and environmental exposure to OTA. Thus, exposure to this mycotoxin may be a poorly recognized problem in our society. OTA has been classified as a group 2b possible carcinogen. Exposure to OTA has been implicated in teratogenesis (fetal malformation), nephrotoxicity, gonadotoxicity and carcinogenesis. The mechanisms for these effects of OTA have not been fully explained. There is an increasing incidence of testis cancer in Western societies combined with the increasing OTA exposures being reported. As well as studying the relationship of OTA to TCC initially, we also plan to examine a possible relationship between OTA and testicular cancer as well as renal cell carcinoma (RCC). To date, very little research into the effects of mycotoxins in humans has been performed. We plan to apply proven techniques of serum analysis using: 1. ELISA or Enzyme Linked Immuno-absorbent Assay which is used to measure the presence of an antibody or antigen in the bloodstream 2. Immunohistochemistry (pathological analysis from resected tumors) 3. High -pressure liquid chromatography (HPLC) of tumor tissue to investigate the role of OTA in human genitourinary cancers. A group of subjects without cancer will be used as a control group.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

St. Josephs Health Care, London, Ontario, Canada

Contact Details

Name: Stephen Pautler, MD, FRCSC

Affiliation: Lawson Health Research Institute

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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