Relationship of Ochratoxin A to Upper Urologic Cancers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00216801
Study type	Observational
Source	Lawson Health Research Institute
Contact
Status	Completed
Phase	N/A
Start date	September 2005
Completion date	April 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00772694` - Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy	Phase 2
Completed	`NCT00705094` - Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients	N/A
Terminated	`NCT00531687` - Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer	Phase 2
Terminated	`NCT00820287` - Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk	N/A
Active, not recruiting	`NCT03142802` - Low-Dose CT - Stage I Testicular Cancer	N/A
Recruiting	`NCT03232541` - The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting	N/A
Completed	`NCT03557177` - Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
Active, not recruiting	`NCT01783145` - Shared Care Follow-up After Chemotherapy for Testicular Cancer
Recruiting	`NCT05611307` - Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Completed	`NCT02573584` - Vascular Fingerprint Validation Study
Recruiting	`NCT05670938` - Follow-up After Surgery for Testicular Cancer
Recruiting	`NCT02994758` - Development of Diagnostics and Treatment of Urological Cancers	N/A
Completed	`NCT02991209` - Study of Testosterone vs Placebo in Testicular Cancer Survivors	Phase 2/Phase 3
Completed	`NCT02602041` - Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Completed	`NCT02092740` - REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg	N/A
Completed	`NCT01482741` - Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging	N/A
Active, not recruiting	`NCT01242072` - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies	Phase 1
Completed	`NCT01242631` - Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer	Phase 2
Completed	`NCT01135849` - B-Receptor Signaling in Cardiomyopathy	N/A
Completed	`NCT00183820` - Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.