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Completed

NCT Number: NCT07210918

Serum Trace Element Levels in Some Gynecological Diseases

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.

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Key information

Conditions

Endometriosis Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Healthy Control Neoplasms Neoplasms by Site Over Cancer Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

sivas Cumhuriyet University

Sivas, Centre, 58146, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Product

Diagnostic Test

5 mL of blood was collected from the right arms of all individuals in 4 different groups. Their serum was obtained.

Primary outcomes

  1. Serum beryllium (Be) measurment

    Time frame: 3 months

    Measured beryllium (Be) levels in the serum samples of study group by ICP-MS baseline.

  2. Serum phosphorus (P) measurment

    Time frame: 3 months

    Phosphorus levels (ppb) in the serum samples of study group by ICP-MS baseline.

  3. Serum vanadium (V) mesurment

    Time frame: 3 months

    Measured vanadium (V) levels (ppb) in the serum samples of study group by ICP-MS baseline.

  4. Serum chromium (Cr) measurment

    Time frame: 3 months

    Measured chromium (Cr) levels in the serum samples of study group by ICP-MS baseline.

  5. Serum manganese (Mn) measurment

    Time frame: 3 months

    Measured manganese (Mn) levels in the serum samples of study group by ICP-MS baseline.

  6. Serum iron (Fe) measurment

    Time frame: 3 months

    Measured iron (Fe) levels in the serum samples of study group by ICP-MS baseline.

  7. Serum cobalt (Co) measurment

    Time frame: 3 months

    Measured cobalt (Co) levels in the serum samples of study group by ICP-MS baseline.

  8. Serum nickel (Ni) measurment

    Time frame: 3 months

    Measured nickel (Ni) levels in the serum samples of study group by ICP-MS baseline.

  9. Serum arsenic (As) measurment

    Time frame: 3 months

    Measured arsenic (As) levels in the serum samples of study group by ICP-MS baseline.

  10. Serum selenium (Se) measurment

    Time frame: 3 months

    Measured selenium (Se) levels in the serum samples of study group by ICP-MS baseline.

  11. Serum molybdenum (Mo) measurment

    Time frame: 3 months

    Measured molybdenum (Mo) levels in the serum samples of study group by ICP-MS baseline.

  12. Serum cadmium (Cd) measurment

    Time frame: 3 months

    Measured cadmium (Cd) levels in the serum samples of study group by ICP-MS baseline.

  13. Serum antimony (Sb) measurment

    Time frame: 3 months

    Measured antimony (Sb) levels in the serum samples of study group by ICP-MS baseline.

  14. Serum lead (Pb) measurment

    Time frame: 3 months

    Measured lead (Pb) levels in the serum samples of study group by ICP-MS baseline.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Serum Trace Element Profiles in Women With Endometriosis, Ovarian and Endometrial Cancer: An ICP-MS-Based Comparative Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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