Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216801
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-09-19
Brief Title:
Relationship of Ochratoxin A to Upper Urologic Cancers
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
The Relationship of Ochratoxin A to Upper Tract TCC Malignancies Testicular Cancer and Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11293 | None | None | None |