TLR4 Polymorphisms and Risk of Skin Cancer

Skin Cancer Clinical Trial

Official title:

TLR4 Polymorphisms and Predisposition for Skin Cancer Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122366
• Other study ID #: F080815001
• Status: Completed
• Start date: February 2, 2009
• Est. completion date: September 27, 2011

Study information

• Verified date: March 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4 (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical studies from our laboratory have shown an association of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms and susceptibility to skin cancer.

Description:

Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptors generally, and TLR4 in particular, appear to play a role in cancer susceptibility as well as tumor immunosuppression and stromal invasion. Of 44 identified SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene, and which was later shown to co-segregate with SNP Thr399Ile-also in the third exon of TLR4.1 This SNP, present in 10% of the general population, has been found associated with gastric cancer, prostate cancer, and nasopharyngeal cancer.2-4 Pre-clinical studies from our laboratory have shown an association of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms and susceptibility to skin cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: September 27, 2011
• Est. primary completion date: September 27, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

• Male or female over the age of 50
• Fitzpatrick skin type I-IV

Exclusion Criteria:

• Tumor types other than basal cell carcinoma, squamous cell carcinoma and melanoma
• Chronic immunosuppression due to transplant antirejection regimen or HIV/AIDS
• Nevoid basal cell carcinoma syndrome, Cowden's syndrome, xeroderma pigmentosum or other syndrome with skin-cancer predisposition
• Known exposure to arsenic or ionizing radiation

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Diagnostic Test:
• Detection of single nucleotide polymorphisms (SNP)
Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood

Locations

Country	Name	City	State
United States	The Kirklin Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	single nucleotide polymorphism	TLR4 SNP Asp299Gly	once during the course of study