Relationship of Ochratoxin A to Upper Urologic Cancers
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|ClinicalTrials.gov Identifier: NCT00216801|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 21, 2009
|Condition or disease|
|Transitional Cell Carcinoma Renal Cell Cancer Testicular Cancer|
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:
- ELISA or Enzyme Linked Immuno-absorbent Assay which is used to measure the presence of an antibody or antigen in the bloodstream
- Immunohistochemistry (pathological analysis from resected tumors)
- 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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||The Relationship of Ochratoxin A to Upper Tract TCC Malignancies, Testicular Cancer, and Renal Cell Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216801
|St. Josephs Health Care|
|London, Ontario, Canada|
|Study Director:||Stephen Pautler, MD, FRCSC||Lawson Health Research Institute|