Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Cancer, Non-Melanoma

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The Kirklin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age less than 50
• Diagnosis of melanoma or other type of cancer
• Non-English speakers

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2012
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 6, 2024

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimated): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: X120713008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No