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CompletedNCT00216801Updated Jan 21, 2009

Relationship of Ochratoxin A to Upper Urologic Cancers

An observational study in Transitional Cell Carcinoma, Renal Cell Cancer and Testicular Cancer, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Transitional Cell Carcinoma
  • Renal Cell Cancer
  • Testicular Cancer

Keywords

  • Upper Tract Transitional Cell (TCC)
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 60 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
06

Study locations

1 site
  • St. Josephs Health Care
    London, Ontario, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00216801
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
First posted
Sep 22, 2005
Start date
Sep 2005
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Jan 21, 2009

Study contacts

Stephen Pautler, MD, FRCSC
study director · London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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