Serum Trace Element Levels in Some Gynecological Diseases

Not Applicable

Completed

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

• Registration Number: NCT07210918
• Lead Sponsor: Cumhuriyet University

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2025-04-24
• Status Verified: 2025-09
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serum trace element Levels (measured by ICP-MS device/ ppb)	3 months	Measured beryllium (Be), phosphorus (P), vanadium (V), chromium (Cr), manganese (Mn), iron (Fe), cobalt (Co), nickel (Ni), arsenic (As), selenium (Se), molybdenum (Mo), cadmium (Cd), antimony (Sb), and lead (Pb) levels in the serum samples of study group by ICP-MS baseline.

Trial Locations

Locations (1)

sivas Cumhuriyet University; Sivas, Centre, Turkey (Türkiye)