Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk

Active, not recruiting

• Conditions: Skin Cancer, Non-Melanoma

• Registration Number: NCT03040492
• Lead Sponsor: University of Alabama at Birmingham

Brief 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. 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 Timeline

• Study Start: 2012-10-31
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SIngle nucleotide polymorphisms (SNP)	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.

Trial Locations

Locations (1)

The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States