TLR4 Polymorphisms and Risk of Skin Cancer

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03122366

Collaborator

(none)

392

Enrollment

Location

163.8

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Cancer	Diagnostic Test: Detection of single nucleotide polymorphisms (SNP)

Study Design

Study Type:

Observational

Actual Enrollment :

392 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

TLR4 Polymorphisms and Predisposition for Skin Cancer Development

Actual Study Start Date :

Feb 2, 2009

Actual Primary Completion Date :

Sep 27, 2011

Anticipated Study Completion Date :

Sep 27, 2022

Outcome Measures

Primary Outcome Measures

single nucleotide polymorphism [once during the course of study]
TLR4 SNP Asp299Gly

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Kirklin Clinic	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nabiha Yusuf, Associate Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03122366

Other Study ID Numbers:

F080815001

First Posted:

Apr 20, 2017

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nabiha Yusuf, Associate Professor, University of Alabama at Birmingham

single nucleotide polymorphisms

Toll-like receptor-4

Additional relevant MeSH terms:

Skin Neoplasms

Study Results

No Results Posted as of Jan 24, 2022