Relationship of Ochratoxin A to Upper Urologic Cancers

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00216801
First received: September 19, 2005
Last updated: January 20, 2009
Last verified: January 2009
  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
Transitional Cell Carcinoma
Renal Cell Cancer
Testicular Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship of Ochratoxin A to Upper Tract TCC Malignancies, Testicular Cancer, and Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Enrollment: 60
Study Start Date: September 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Must have resectable non-metastatic upper tract transitional cell carcinoma, renal cell carcinoma, or testicular carcinoma.

Criteria

Inclusion Criteria:

  • Study Group

    1. Informed consent
    2. Must have resectable non-metastatic upper tract transitional cell carcinoma, renal cell carcinoma, or testicular 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216801

Locations
Canada, Ontario
St. Josephs Health Care
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Study Director: Stephen Pautler, MD, FRCSC Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. S. Pautler, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00216801     History of Changes
Other Study ID Numbers: R-05-082, 11293
Study First Received: September 19, 2005
Last Updated: January 20, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Upper Tract Transitional Cell (TCC)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Testicular Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Ochratoxin A
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014