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临床试验/NCT05277961
NCT05277961进行中(未招募)不适用

Quantification of DNA Repair Products in the Urine After Ultraviolet Radiation of the Skin

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
Determination of days where the concentration of excreted thymine dimers (a marker of DNA damage) is the highest in the urine after UVR exposure of the skin.

研究概览

简要总结

Purpose of the experiment The investigators know that DNA damage is formed in the skin by sun exposure of the thymine-dimer type. Many of these injuries are repaired and excreted through the urine.

The purpose of the study is to quantify DNA damage in the urine after ultraviolet (UV) irradiation of the skin in healthy subjects. The investigators would like to investigate which day after two different irradiation regimens the highest secretion of thymine dimers occurs. If the investigators establish such a test system, it will be possible to test potential photoprotective substances or potential photocarcinogenic substances.

Method of the experiment, design, and examination procedures The subjects (n = 16-20) are recruited by a post on Bispebjerg's hospital website. Based on this, subjects are divided into 2 groups of 8-10 people. Group 1 is irradiated 3 times with 1 standard erythema dose (SED). 1 SED corresponds to approx. 10 minutes sun around 13 pm on a good Danish summer day. Group 2 is irradiated once with 3 SED, which corresponds to approx. 30 minutes around 13 pm on a good Danish summer day. The irradiation is carried out on day 1 for group 2 and days 1, 2 and 3 for group 1.

Subjects are irradiated in a full-body UV cabin (Waldmann, Willing-Schwenningen, Germany) with 26 F85 / 100W UV6 tubes (290-350 nm, broad-spectrum). 13 seconds of illumination, equivalent to 1 SED. The subjects are standing in the cabin and have a screen on so that their eyes and face are not exposed to radiation. When irradiated, the subjects must only wear underwear, which for men are underpants/boxer shorts, while for women it is bras and panties. The experiment is performed between October and March, to avoid that the subjects do not simultaneously receive UV radiation from the sun and thus form DNA damage.

Subjects must collect morning urine in dispensed containers and must store it in their own freezer until the final visit. Morning urine (2x 50 mL) is collected before irradiation, called day 1, and even until day 8 after the last exposure, ie. day 10 for group 1 and day 8 for group 2. Before the first exposure, pigment and redness are measured on the subjects. Pigment and redness measurements are performed on the back, chest, and shoulder.

详细描述

Project title:

Determination of DNA repair products in urine after UV irradiation of the skin

  1. Purpose

Problem definition

DNA damage is formed in the skin by sun exposure. The most common DNA damage is called thymine dimers. Many of these injuries are repaired by "Nucleotide excision repair" (NER) and excreted through the urine. The importance of this repair mechanism is seen in patients with defects in their NER, who have a very high risk of developing skin cancer. The investigators want to be able to quantify the amount of thymine dimers in the urine after ultraviolet (UV) irradiation of the skin. With the establishment of such a test system, it will eventually be possible to test potential photoprotective substances or potential photocarcinogenic substances based on damage measured in the urine after a known UV dose. The investigators would like to investigate when the highest secretion of this type of DNA damage occurs using two different irradiation regimens. It has previously been possible to quantify thymine dimers in the urine using an isotope method, but that method is no longer available and it is desirable to avoid isotopes. The investigators have developed a new method based on Ultra High-pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Determination of days where the concentration of excreted thymine dimers (a marker of DNA damage) is the highest in the urine after UVR exposure of the skin.

时间窗: 10 days

Each participant of group 1 will provide a total of 1000 ml (2 x50 ml x10 days) of urine and participants of group 2 will provide a total of 800 ml (2 x 50 ml x 8 days) of urine at the end of the experiment. UVR induced thymine dimers repaired and excreted in the urine will be quantified (by Ultra High-pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS) from urine collected before and after irradiation regimes. The highest concentration of thymine dimers in urine will indicate the most optimal time for urine collection after irradiation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catharina Margrethe Lerche

Associate Professor

Bispebjerg Hospital

研究点 (2)

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