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临床试验/NCT03470857
NCT03470857已完成不适用

Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.

Nicolaus Copernicus University3 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
3
主要终点
Thiobarbituric acid reactive substances (Malondialdehyde)

研究概览

简要总结

The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-[fluorine-18]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.

详细描述

FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.

Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.

In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • sign informed consent form for participation in the study

排除标准

  • other diseases,
  • bad feeling of the studied individual on the day of the study,
  • the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators.

结局指标

主要结局

Thiobarbituric acid reactive substances (Malondialdehyde)

时间窗: 1 day (Single measurement)

Secondary lipid peroxidation product

Acid Phosphatase

时间窗: 1 day (Single measurement)

Lysosomal enzyme

8-iso-Prostaglandin F2alpha

时间窗: 1 day (Single measurement)

Secondary lipid peroxidation product

Arylsulfatase

时间窗: 1 day (Single measurement)

Lysosomal enzyme

Alpha-1-Antitrypsin

时间窗: 1 day (Single measurement)

Serine protease inhibitor

4-Hydroxynonenal

时间窗: 1 day (Single measurement)

Secondary lipid peroxidation product

Cathepsin D

时间窗: 1 day (Single measurement)

Lysosomal enzyme

Conjugated Dienes

时间窗: 1 day (Single measurement)

Primary lipid peroxidation product

Superoxide Dismutase

时间窗: 1 day (Single measurement)

Antioxidant enzyme

Catalase

时间窗: 1 day (Single measurement)

Antioxidant enzyme

Glutathione Peroxidase

时间窗: 1 day (Single measurement)

Antioxidant enzyme

Total Antioxidant Capacity

时间窗: 1 day (Single measurement)

Total antioxidant potential of blood serum in the participant

Vitamins A and E

时间窗: 1 day (Single measurement)

Low molecular weight antioxidants

次要结局

  • FDG PET/CT scanning(1 day (Single measurement))

研究者

发起方
Nicolaus Copernicus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paweł Sutkowy

Assistant professor

Nicolaus Copernicus University

研究点 (3)

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