Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03040492
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nabiha Yusuf, 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.

Condition or disease
Skin Cancer, Non-Melanoma

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risks in Alabama Population
Actual Study Start Date : October 31, 2012
Actual Primary Completion Date : May 1, 2015
Estimated Study Completion Date : June 6, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   None Retained
Biospecimens retained for further analysis of polymorphisms


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040492


Locations
Layout table for location information
United States, Alabama
The Kirklin Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham

Layout table for additonal information
Responsible Party: Nabiha Yusuf, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03040492     History of Changes
Other Study ID Numbers: X120713008
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents