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Recruiting NCT04122456

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

No phase Interventional Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultraviolet B Radiation, No Ultraviolet B Radiation.
Who it may be relevant to
Registry conditions: Skin Cancer. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Radiation Ultraviolet B Radiation
    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.
  • Other No Ultraviolet B Radiation
    One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

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. [Time frame: After 1 hour incubation from ultraviolet B radiation exposure.]
  • Expression levels of core clock genes at two times of the day in the skin of day and night shift works. [Time frame: After 1 hour incubation from ultraviolet B radiation exposure.]
  • Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers. [Time frame: After 1 hour incubation from ultraviolet B radiation exposure.]
  • Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers. [Time frame: After 1 hour incubation from ultraviolet B radiation exposure.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Wright State Physicians — Fairborn

Identifiers

NCT: NCT04122456 · 06753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗