Skin Cancer, Non-MelanomaNCT03040492
Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk
An observational study of Skin Cancer, Non-Melanoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Non-Melanoma
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2012to 30 Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient group consisted of 100 subjects with a BCC or SCC diagnosis, visiting the Dermatology Clinics at The Kirklin Clinic at the University of Alabama at Birmingham between 2012 and 2014
Who may be able to join
- Patients with non-melanoma skin cancer (cases)
- Patients without non-melanoma skin cancer or history of non-melanoma skin cancer (controls)
- Age 50 and older
- Native English speakers
- Patients at Kirklin Clinic
Who cannot join
- Age less than 50
- Diagnosis of melanoma or other type of cancer
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risks in Alabama Population
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics.
Read the detailed description
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics. By identifying the VDR polymorphisms for the Apa1, Taq1, Bsm1, and Fok1 genes within the participant population and comparing the genotypes to controls, the investigators hope to demonstrate which gene polymorphisms indicate an increased risk for SCC or BCC.
Inclusion- patients with a non-melanoma skin cancer. Participants must be 50 years old or older. Controls- patients without non-melanoma skin cancer and who have no family history of skin cancer. They must also be 50 years old or older; Inclusion for both groups- English speakers and patients at the Kirklin Clinic during the months of our data collection. Exclusion criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or other type of cancer, or who are non-English speakers.
- Conditions
- Skin Cancer, Non-Melanoma
- Medical subject headings
- Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
SIngle nucleotide polymorphisms (SNP)
Number of patients with the presence or absence of VDR SNP in their DNA isolated from their blood samples. PCR will be performed on the DNA samples for using specific primers for SNP, and the PCR products will be sequenced for detection of SNP.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start31 Oct 2012
- Primary completion30 Jun 2013
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer, Non-MelanomaStudies 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
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040492
- Sponsor's protocol ID
- X120713008
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2017
- Last updated
- 8 Sep 2025
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risks in Alabama Population
- ClinicalTrials.gov ID
- NCT03040492
- Acronym / sponsor ID
- X120713008
- Conditions
- Skin Cancer, Non-Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Oct 2012 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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.
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics.
Detailed description
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics. By identifying the VDR polymorphisms for the Apa1, Taq1, Bsm1, and Fok1 genes within the participant population and comparing the genotypes to controls, the investigators hope to demonstrate which gene polymorphisms indicate an increased risk for SCC or BCC.
Inclusion- patients with a non-melanoma skin cancer. Participants must be 50 years old or older. Controls- patients without non-melanoma skin cancer and who have no family history of skin cancer. They must also be 50 years old or older; Inclusion for both groups- English speakers and patients at the Kirklin Clinic during the months of our data collection. Exclusion criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or other type of cancer, or who are non-English speakers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient group consisted of 100 subjects with a BCC or SCC diagnosis, visiting the Dermatology Clinics at The Kirklin Clinic at the University of Alabama at Birmingham between 2012 and 2014
Key inclusion criteria (5 listed)
- Patients with non-melanoma skin cancer (cases)
- Patients without non-melanoma skin cancer or history of non-melanoma skin cancer (controls)
- Age 50 and older
- Native English speakers
- Patients at Kirklin Clinic
Key exclusion criteria (3 listed)
- Age less than 50
- Diagnosis of melanoma or other type of cancer
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SIngle nucleotide polymorphisms (SNP)
Time frame: 2 years
Number of patients with the presence or absence of VDR SNP in their DNA isolated from their blood samples. PCR will be performed on the DNA samples for using specific primers for SNP, and the PCR products will be sequenced for detection of SNP.
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 8 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Non-Melanoma, 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 5 inclusion and 3 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 8 Sep 2025. 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 polymorphisms (SNP) (time frame: 2 years). 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 8 Sep 2025.