Serum Trace Element Levels in Some Gynecological Diseases

Cumhuriyet University

Status: Completed

Conditions: Healthy Control; Endometrial Cancer; Over Cancer; Endometriosis

Treatments: Diagnostic Test: Blood Product

Study type: Interventional

Funder types: Other

Identifiers

NCT07210918

Cütam Dilara

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Control group

Experimental group

Description:

Consists of healthy individuals

Treatment:

Diagnostic Test: Blood Product

Endometriosis group

Experimental group

Description:

Consists of individuals diagnosed with endometriosis

Treatment:

Diagnostic Test: Blood Product

Overian cancer group

Experimental group

Description:

Consists of individuals diagnosed with ovarian cancer

Treatment:

Diagnostic Test: Blood Product

Endometrial cancer

Experimental group

Description:

Consists of individuals diagnosed with endometrial cancer

Treatment:

Diagnostic Test: Blood Product