EndometriosisNCT07210918
Serum Trace Element Levels in Some Gynecological Diseases
A study testing Blood Product in people with Endometriosis and Endometrial Cancer, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometrial Cancer, Over Cancer
- What is being tested?
- Blood Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2025to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
sivas Cumhuriyet University
Sivas, Centre, 58146
About this study
Official title: Serum Trace Element Profiles in Women With Endometriosis, Ovarian and Endometrial Cancer: An ICP-MS-Based Comparative Study
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.
Read the 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
- Conditions
- Endometriosis, Endometrial Cancer, Over Cancer, Healthy Control
- Being tested
- Blood Product
- Keywords
- trace elements, endometriosis, endometrial cancer, overian cancer
- Medical subject headings
- Endometriosis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ProductDiagnostic test
5 mL of blood was collected from the right arms of all individuals in 4 different groups. Their serum was obtained.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Consists of healthy individuals Receives: Diagnostic Test: Blood Product |
| Endometriosis group | Experimental | Consists of individuals diagnosed with endometriosis Receives: Diagnostic Test: Blood Product |
| Overian cancer group | Experimental | Consists of individuals diagnosed with ovarian cancer Receives: Diagnostic Test: Blood Product |
| Endometrial cancer | Experimental | Consists of individuals diagnosed with endometrial cancer Receives: Diagnostic Test: Blood Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum beryllium (Be) measurment
Measured beryllium (Be) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum phosphorus (P) measurment
Phosphorus levels (ppb) in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum vanadium (V) mesurment
Measured vanadium (V) levels (ppb) in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum chromium (Cr) measurment
Measured chromium (Cr) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum manganese (Mn) measurment
Measured manganese (Mn) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum iron (Fe) measurment
Measured iron (Fe) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum cobalt (Co) measurment
Measured cobalt (Co) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum nickel (Ni) measurment
Measured nickel (Ni) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum arsenic (As) measurment
Measured arsenic (As) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum selenium (Se) measurment
Measured selenium (Se) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum molybdenum (Mo) measurment
Measured molybdenum (Mo) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum cadmium (Cd) measurment
Measured cadmium (Cd) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum antimony (Sb) measurment
Measured antimony (Sb) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Serum lead (Pb) measurment
Measured lead (Pb) levels in the serum samples of study group by ICP-MS baseline.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start24 Apr 2025
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We have four groups in the study. Blood will be drawn from each group only once. No other interventions will be performed.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ulger Ozbek, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210918
- Sponsor's protocol ID
- Cütam Dilara
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Trace Element Profiles in Women With Endometriosis, Ovarian and Endometrial Cancer: An ICP-MS-Based Comparative Study
- ClinicalTrials.gov ID
- NCT07210918
- Acronym / sponsor ID
- Cütam Dilara
- Conditions
- Endometriosis, Endometrial Cancer, Over Cancer, Healthy Control
- Keywords
- trace elements, endometriosis, endometrial cancer, overian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- We have four groups in the study. Blood will be drawn from each group only once. No other interventions will be performed.
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Diagnostic Test: Blood ProductConsists of healthy individuals |
| Endometriosis group | Experimental | Diagnostic Test: Blood ProductConsists of individuals diagnosed with endometriosis |
| Overian cancer group | Experimental | Diagnostic Test: Blood ProductConsists of individuals diagnosed with ovarian cancer |
| Endometrial cancer | Experimental | Diagnostic Test: Blood ProductConsists of individuals diagnosed with endometrial cancer |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Product5 mL of blood was collected from the right arms of all individuals in 4 different groups. Their serum was obtained. | Diagnostic test | Control group, Endometrial cancer, Endometriosis group, Overian cancer group |
Primary outcome
Serum beryllium (Be) measurment
Time frame: 3 months
Measured beryllium (Be) levels in the serum samples of study group by ICP-MS baseline.
Serum phosphorus (P) measurment
Time frame: 3 months
Phosphorus levels (ppb) in the serum samples of study group by ICP-MS baseline.
Serum vanadium (V) mesurment
Time frame: 3 months
Measured vanadium (V) levels (ppb) in the serum samples of study group by ICP-MS baseline.
Serum chromium (Cr) measurment
Time frame: 3 months
Measured chromium (Cr) levels in the serum samples of study group by ICP-MS baseline.
Serum manganese (Mn) measurment
Time frame: 3 months
Measured manganese (Mn) levels in the serum samples of study group by ICP-MS baseline.
Serum iron (Fe) measurment
Time frame: 3 months
Measured iron (Fe) levels in the serum samples of study group by ICP-MS baseline.
Serum cobalt (Co) measurment
Time frame: 3 months
Measured cobalt (Co) levels in the serum samples of study group by ICP-MS baseline.
Serum nickel (Ni) measurment
Time frame: 3 months
Measured nickel (Ni) levels in the serum samples of study group by ICP-MS baseline.
Serum arsenic (As) measurment
Time frame: 3 months
Measured arsenic (As) levels in the serum samples of study group by ICP-MS baseline.
Serum selenium (Se) measurment
Time frame: 3 months
Measured selenium (Se) levels in the serum samples of study group by ICP-MS baseline.
Serum molybdenum (Mo) measurment
Time frame: 3 months
Measured molybdenum (Mo) levels in the serum samples of study group by ICP-MS baseline.
Serum cadmium (Cd) measurment
Time frame: 3 months
Measured cadmium (Cd) levels in the serum samples of study group by ICP-MS baseline.
Serum antimony (Sb) measurment
Time frame: 3 months
Measured antimony (Sb) levels in the serum samples of study group by ICP-MS baseline.
Serum lead (Pb) measurment
Time frame: 3 months
Measured lead (Pb) levels in the serum samples of study group by ICP-MS baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Product in people with Endometriosis and Endometrial Cancer, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum beryllium (Be) measurment (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.