Serum Trace Element Profiles in Women With Endometriosis, Ovarian and Endometrial Cancer: An ICP-MS-Based Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Serum beryllium (Be) measurment
研究概览
简要总结
The aim of this clinical study is to measure the levels of various trace elements in the blood serum of women with various gynecological diseases and to compare them with healthy controls. The main questions it aims to answer are:
- Do trace element levels increase or decrease in endometriosis?
- Do trace element levels increase or decrease in ovarian cancer patients?
- Do trace element levels increase or decrease in endometrial cancer patients?
Participants:
Each member of the study group will visit the clinic only once and donate 5 ml of blood.
详细描述
However, the serum trace elements profiles of individuals with endometriosis, ovarian cancer (OC), and endometrial cancer (EC) are not fully known. The purpose of this study is to examine the levels of trace element profiles in the blood serum of healthy people and individuals with gynecological disorders.
The study group comprised of 40 women divided into four groups (n=10 each); endometriosis, endometrial cancer and ovarian cancer, and control group who were obstetrically and demographically similar. Inductively coupled plasma-mass spectrometry (ICP-MS) was used to assess serum trace element levels of lead, beryllium, vanadium, chromium, manganese, iron, cobalt, nickel, arsenic, selenium, molybdenum, cadmium, antimony, and phosphorus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Not having received chemotherapy, radiotherapy or immunotherapy in the last three months
- •For the endometriosis group: histopathologically or laparoscopically confirmed endometriosis
- •For the ovarian cancer group: histopathologically confirmed epithelial ovarian cancer
- •For the endometrial cancer group: histopathologically confirmed endometrial adenocarcinoma
- •For the control group: healthy individuals who underwent surgery for benign gynecological causes (e.g., myoma, benign cyst) and who were not diagnosed with malignancy/endometriosis
排除标准
- •Chronic systemic diseases (e.g., chronic renal failure, liver disease, severe cardiac disease)
- •Diseases that may affect metabolism or trace element levels (e.g., Wilson's disease, hemochromatosis)
- •Use of dietary supplements containing minerals or trace elements within the past 6 months
- •Environmental or occupational heavy metal exposure (e.g., mining, metallurgy, battery industry workers)
- •Pregnancy or breastfeeding
- •History of acute infection or inflammatory disease
- •History of recurrent surgery or advanced metastatic cancer (as this may alter serum parameters)
- •Psychiatric or cognitive disorders that preclude participation in the study
结局指标
主要结局
Serum beryllium (Be) measurment
时间窗: 3 months
Measured beryllium (Be) levels in the serum samples of study group by ICP-MS baseline.
Serum phosphorus (P) measurment
时间窗: 3 months
Phosphorus levels (ppb) in the serum samples of study group by ICP-MS baseline.
Serum vanadium (V) mesurment
时间窗: 3 months
Measured vanadium (V) levels (ppb) in the serum samples of study group by ICP-MS baseline.
Serum chromium (Cr) measurment
时间窗: 3 months
Measured chromium (Cr) levels in the serum samples of study group by ICP-MS baseline.
Serum manganese (Mn) measurment
时间窗: 3 months
Measured manganese (Mn) levels in the serum samples of study group by ICP-MS baseline.
Serum iron (Fe) measurment
时间窗: 3 months
Measured iron (Fe) levels in the serum samples of study group by ICP-MS baseline.
Serum cobalt (Co) measurment
时间窗: 3 months
Measured cobalt (Co) levels in the serum samples of study group by ICP-MS baseline.
Serum nickel (Ni) measurment
时间窗: 3 months
Measured nickel (Ni) levels in the serum samples of study group by ICP-MS baseline.
Serum arsenic (As) measurment
时间窗: 3 months
Measured arsenic (As) levels in the serum samples of study group by ICP-MS baseline.
Serum selenium (Se) measurment
时间窗: 3 months
Measured selenium (Se) levels in the serum samples of study group by ICP-MS baseline.
Serum molybdenum (Mo) measurment
时间窗: 3 months
Measured molybdenum (Mo) levels in the serum samples of study group by ICP-MS baseline.
Serum cadmium (Cd) measurment
时间窗: 3 months
Measured cadmium (Cd) levels in the serum samples of study group by ICP-MS baseline.
Serum antimony (Sb) measurment
时间窗: 3 months
Measured antimony (Sb) levels in the serum samples of study group by ICP-MS baseline.
Serum lead (Pb) measurment
时间窗: 3 months
Measured lead (Pb) levels in the serum samples of study group by ICP-MS baseline.
次要结局
未报告次要终点
研究者
Dilara Ulger Ozbek
Dr.
Cumhuriyet University