Clinical Trial: Relationship of Ochratoxin A to Upper Urologic Cancers

This study is not yet open for patient recruitment.
Verified by Lawson Health Research Institute September 2005

Sponsored by: Lawson Health Research Institute
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00216801

Purpose

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.
Condition
Upper Tract Transitional Cell(TCC),
Renal Cell Cancer
Testicular Cancer

MedlinePlus related topics:  Cancer;   Kidney Cancer;   Testicular Cancer

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study

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

Further Study Details: 

Expected Total Enrollment:  60

Study start: September 2005

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 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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Study Group

    1. Informed Consent
    2. Must have resectable non-metastatic Upper tract transitional cell carcinoma, renal cell carcinoma ortesticular carcinoma.
    3. Willingness to be followed for survival data.
  • Control Group

    1. Informed Consent
    2. No history of carcinoma

Exclusion Criteria:

  1. Metastatic Upper tract transitional cell carcinoma, renal cell carcinoma or testicular carcinoma.
  2. Any other ongoing or previous malignancy other than basal or squamous cell skin cancer.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00216801

Steve Pautler, MD. FRCSC      519-646-6384    Stephen.Pautler@sjhc.london.on.ca

Canada, Ontario
      St. Josephs Health Care, London,  Ontario,  Canada
Kristine Carter, RN  519-685-8300  Ext. 57350    kris.carter@lhsc.on.ca 

Study chairs or principal investigators

Stephen Pautler, MD, FRCSC,  Study Director,  Lawson Health Research Institute   

More Information

Study ID Numbers:  R--05-082
Last Updated:  September 21, 2005
Record first received:  September 19, 2005
ClinicalTrials.gov Identifier:  NCT00216801
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-27

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