TLR4 Polymorphisms and Risk of Skin Cancer

NCT03122366 | Completed

• 1 other identifier: F080815001
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Cancer

Keywords

single nucleotide polymorphisms; Toll-like receptor-4

Outcome Measures

Primary Outcomes (1)

• single nucleotide polymorphism

  TLR4 SNP Asp299Gly

  once during the course of study

Interventions

Detection of single nucleotide polymorphisms (SNP) DIAGNOSTIC_TEST

Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

400 patients age 50 and older (case group) will be enrolled at the time of presentation for skin cancer excision surgery. These patients will be stratified into melanoma and non-melanoma skin cancer subgroups, and the non-melanoma subgroup will be further divided into prior and no prior history of skin cancer. All groups will have blood drawn at the time of enrollment. 400 patients age 50 and older (control group) with no personal history of skin cancer will be enrolled at our clinical trials unit. These patients will be stratified into family history and no family history of skin cancer subgroups, and will have blood drawn at the time of enrollment.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nabiha Yusuf

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: February 2, 2009
• Primary Completion: September 27, 2011
• Study Completion: September 27, 2011
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)