Skin CancerNCT03122366
TLR4 Polymorphisms and Risk of Skin Cancer
An observational study of Skin Cancer, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Detection of single nucleotide polymorphisms (SNP)
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2009to 27 Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or female over the age of 50
- Fitzpatrick skin type I-IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TLR4 Polymorphisms and Predisposition for Skin Cancer Development
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.
Read the detailed 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.
- Conditions
- Skin Cancer
- Being tested
- Detection of single nucleotide polymorphisms (SNP)
- Keywords
- single nucleotide polymorphisms, Toll-like receptor-4
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of single nucleotide polymorphisms (SNP)Diagnostic test
Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood
What is being measured
The primary outcome is the main question the study is designed to answer.
single nucleotide polymorphism
TLR4 SNP Asp299Gly
Measured: once during the course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start2 Feb 2009
- Primary completion27 Sep 2011
- Study completion27 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabiha Yusuf, University of Alabama at Birmingham
- Investigators
- Nabiha Yusuf, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122366
- Sponsor's protocol ID
- F080815001
- Status last verified
- Mar 2023
- First submitted
- 17 Apr 2017
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TLR4 Polymorphisms and Predisposition for Skin Cancer Development
- ClinicalTrials.gov ID
- NCT03122366
- Acronym / sponsor ID
- F080815001
- Conditions
- Skin Cancer
- Keywords
- single nucleotide polymorphisms, Toll-like receptor-4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Feb 2009 (actual)
- Primary completion
- 27 Sep 2011 (actual)
- Study completion
- 27 Sep 2011 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female over the age of 50
- Fitzpatrick skin type I-IV
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of single nucleotide polymorphisms (SNP)Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood | Diagnostic test | – |
Primary outcome
single nucleotide polymorphism
Time frame: once during the course of study
TLR4 SNP Asp299Gly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabiha Yusuf principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single nucleotide polymorphism (time frame: once during the course of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.