NCT07210918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

September 30, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

trace elementsendometriosisendometrial canceroverian cancer

Outcome Measures

Primary Outcomes (14)

  • Serum beryllium (Be) measurment

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

    3 months

  • Serum phosphorus (P) measurment

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

    3 months

  • Serum vanadium (V) mesurment

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

    3 months

  • Serum chromium (Cr) measurment

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

    3 months

  • Serum manganese (Mn) measurment

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

    3 months

  • Serum iron (Fe) measurment

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

    3 months

  • Serum cobalt (Co) measurment

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

    3 months

  • Serum nickel (Ni) measurment

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

    3 months

  • Serum arsenic (As) measurment

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

    3 months

  • Serum selenium (Se) measurment

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

    3 months

  • Serum molybdenum (Mo) measurment

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

    3 months

  • Serum cadmium (Cd) measurment

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

    3 months

  • Serum antimony (Sb) measurment

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

    3 months

  • Serum lead (Pb) measurment

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

    3 months

Study Arms (4)

Control group

EXPERIMENTAL

Consists of healthy individuals

Diagnostic Test: Blood Product

Endometriosis group

EXPERIMENTAL

Consists of individuals diagnosed with endometriosis

Diagnostic Test: Blood Product

Overian cancer group

EXPERIMENTAL

Consists of individuals diagnosed with ovarian cancer

Diagnostic Test: Blood Product

Endometrial cancer

EXPERIMENTAL

Consists of individuals diagnosed with endometrial cancer

Diagnostic Test: Blood Product

Interventions

Blood ProductDIAGNOSTIC_TEST

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

Control groupEndometrial cancerEndometriosis groupOverian cancer group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince this study is about gynecological diseases, female participants must be selected.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sivas Cumhuriyet University

Sivas, Centre, 58146, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EndometriosisEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: We have four groups in the study. Blood will be drawn from each group only once. No other interventions will be performed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

April 24, 2025

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations