NCT03040492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

January 27, 2017

Last Update Submit

September 5, 2025

Conditions

Skin Cancer, Non-Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: NONE RETAINED

Biospecimens retained for further analysis of polymorphisms

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 2, 2017

Study Start

October 31, 2012

Primary Completion

June 30, 2013

Study Completion

June 30, 2017

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)