search
Back to results

DNA Repair Activity in the Skin of Day and Night Shift Workers

Primary Purpose

Skin Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultraviolet B Radiation
No Ultraviolet B Radiation
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Cancer

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male/Female
  • Fair skin (Fitzpatrick types I and II)
  • Age 18 to 40
  • Able to comprehend procedures/risks
  • Primarily work and are awake during normal daylight hours (6 am to 6 pm), or primarily work and are awake during night shifts hours (between the hours of 6 pm and 6 am) or may work a mixture of these shifts over the past 3 months. Rotating shifts will be categorized based on the majority of hours worked on average during the last 3 months. Able to fill out a 3-month calendar of work schedule.

Exclusion Criteria:

  • Known photosensitivity
  • Currently on photosensitizing medications
  • Diabetes Mellitus
  • On any hormonal agents (e.g., birth control pills)
  • History of abnormal scarring
  • History of skin infections
  • History of skin cancers
  • History of sleep disorders such as sleep apnea or insomnia
  • Known allergy to lidocaine local anesthetic
  • Pregnancy or nursing
  • Other serious health issues

Sites / Locations

  • Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Day Shift Work Schedule

Night Shift Work Schedule

Arm Description

Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Outcomes

Primary Outcome Measures

Expression level of the DNA repair factor XPA at two times of the day in the skin of day and night shift workers.
Reverse transcription quantitative PCR (RT-qPCR) and immunohistochemistry will be used to measure XPA expression at the mRNA and protein level, respectively, in skin samples obtained at 8 am and 4 pm.
Expression levels of core clock genes at two times of the day in the skin of day and night shift works.
Reverse Transcription Quantitative PCR (RT-qPCR) is used to measure the core circadian clock gene expression at the mRNA level in the skin samples obtained at 8 AM and 4 PM.
Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers.
A biochemical assay of nucleotide excision repair is used to measure NER in the skin samples obtained at 8 AM and 4 PM.
Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers.
Immunohistochemistry is used to measure DNA damage kinase signaling (phosphorylated Chk1 and p53) in the skin samples obtained at 8 AM and 4 PM.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2019
Last Updated
February 22, 2023
Sponsor
Wright State University
search

1. Study Identification

Unique Protocol Identification Number
NCT04122456
Brief Title
DNA Repair Activity in the Skin of Day and Night Shift Workers
Official Title
Pilot Study on DNA Repair Activity in the Skin of Day and Night Shift Workers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The purpose of this study is to test how the skin of night shift workers responds to artificial sunlight (ultraviolet B radiation; UVB) at two different times of the day in comparison to normal day shift workers. After the skin biopsies are obtained, they will be brought to the laboratory to be exposed to UVB radiation and to measure UVB responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Day Shift Work Schedule
Arm Type
Experimental
Arm Description
Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.
Arm Title
Night Shift Work Schedule
Arm Type
Experimental
Arm Description
Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.
Intervention Type
Radiation
Intervention Name(s)
Ultraviolet B Radiation
Intervention Description
One skin punch biopsy will be taken to the laboratory for exposure to ultraviolet B radiation. After 1-hour incubation, the biopsies will be bisected in half.
Intervention Type
Other
Intervention Name(s)
No Ultraviolet B Radiation
Intervention Description
One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.
Primary Outcome Measure Information:
Title
Expression level of the DNA repair factor XPA at two times of the day in the skin of day and night shift workers.
Description
Reverse transcription quantitative PCR (RT-qPCR) and immunohistochemistry will be used to measure XPA expression at the mRNA and protein level, respectively, in skin samples obtained at 8 am and 4 pm.
Time Frame
After 1 hour incubation from ultraviolet B radiation exposure.
Title
Expression levels of core clock genes at two times of the day in the skin of day and night shift works.
Description
Reverse Transcription Quantitative PCR (RT-qPCR) is used to measure the core circadian clock gene expression at the mRNA level in the skin samples obtained at 8 AM and 4 PM.
Time Frame
After 1 hour incubation from ultraviolet B radiation exposure.
Title
Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers.
Description
A biochemical assay of nucleotide excision repair is used to measure NER in the skin samples obtained at 8 AM and 4 PM.
Time Frame
After 1 hour incubation from ultraviolet B radiation exposure.
Title
Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers.
Description
Immunohistochemistry is used to measure DNA damage kinase signaling (phosphorylated Chk1 and p53) in the skin samples obtained at 8 AM and 4 PM.
Time Frame
After 1 hour incubation from ultraviolet B radiation exposure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male/Female Fair skin (Fitzpatrick types I and II) Age 18 to 40 Able to comprehend procedures/risks Primarily work and are awake during normal daylight hours (6 am to 6 pm), or primarily work and are awake during night shifts hours (between the hours of 6 pm and 6 am) or may work a mixture of these shifts over the past 3 months. Rotating shifts will be categorized based on the majority of hours worked on average during the last 3 months. Able to fill out a 3-month calendar of work schedule. Exclusion Criteria: Known photosensitivity Currently on photosensitizing medications Diabetes Mellitus On any hormonal agents (e.g., birth control pills) History of abnormal scarring History of skin infections History of skin cancers History of sleep disorders such as sleep apnea or insomnia Known allergy to lidocaine local anesthetic Pregnancy or nursing Other serious health issues
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager, Clinical Research Operations
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Specialist
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Travers, MD, PhD
Organizational Affiliation
Wright State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pharmacology Translational Unit
Phone
937-245-7500

12. IPD Sharing Statement

Learn more about this trial

DNA Repair Activity in the Skin of Day and Night Shift Workers

We'll reach out to this number within 24 hrs