Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07210918
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Trace Element Levels in Some Gynecological Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We have four groups in the study. Blood will be drawn from each group only once. No other interventions will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum beryllium (Be) measurment', 'timeFrame': '3 months', 'description': 'Measured beryllium (Be) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum phosphorus (P) measurment', 'timeFrame': '3 months', 'description': 'Phosphorus levels (ppb) in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum vanadium (V) mesurment', 'timeFrame': '3 months', 'description': 'Measured vanadium (V) levels (ppb) in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum chromium (Cr) measurment', 'timeFrame': '3 months', 'description': 'Measured chromium (Cr) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum manganese (Mn) measurment', 'timeFrame': '3 months', 'description': 'Measured manganese (Mn) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum iron (Fe) measurment', 'timeFrame': '3 months', 'description': 'Measured iron (Fe) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum cobalt (Co) measurment', 'timeFrame': '3 months', 'description': 'Measured cobalt (Co) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum nickel (Ni) measurment', 'timeFrame': '3 months', 'description': 'Measured nickel (Ni) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum arsenic (As) measurment', 'timeFrame': '3 months', 'description': 'Measured arsenic (As) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum selenium (Se) measurment', 'timeFrame': '3 months', 'description': 'Measured selenium (Se) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum molybdenum (Mo) measurment', 'timeFrame': '3 months', 'description': 'Measured molybdenum (Mo) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum cadmium (Cd) measurment', 'timeFrame': '3 months', 'description': 'Measured cadmium (Cd) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum antimony (Sb) measurment', 'timeFrame': '3 months', 'description': 'Measured antimony (Sb) levels in the serum samples of study group by ICP-MS baseline.'}, {'measure': 'Serum lead (Pb) measurment', 'timeFrame': '3 months', 'description': 'Measured lead (Pb) levels in the serum samples of study group by ICP-MS baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trace elements', 'endometriosis', 'endometrial cancer', 'overian cancer'], 'conditions': ['Endometriosis', 'Endometrial Cancer', 'Over Cancer', 'Healthy Control']}, 'descriptionModule': {'briefSummary': '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:\n\n* Do trace element levels increase or decrease in endometriosis?\n* Do trace element levels increase or decrease in ovarian cancer patients?\n* Do trace element levels increase or decrease in endometrial cancer patients?\n\nParticipants:\n\nEach member of the study group will visit the clinic only once and donate 5 ml of blood.', 'detailedDescription': '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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since this study is about gynecological diseases, female participants must be selected.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Not having received chemotherapy, radiotherapy or immunotherapy in the last three months\n* For the endometriosis group: histopathologically or laparoscopically confirmed endometriosis\n* For the ovarian cancer group: histopathologically confirmed epithelial ovarian cancer\n* For the endometrial cancer group: histopathologically confirmed endometrial adenocarcinoma\n* 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\n\nExclusion Criteria:\n\n* Chronic systemic diseases (e.g., chronic renal failure, liver disease, severe cardiac disease)\n* Diseases that may affect metabolism or trace element levels (e.g., Wilson's disease, hemochromatosis)\n* Use of dietary supplements containing minerals or trace elements within the past 6 months\n* Environmental or occupational heavy metal exposure (e.g., mining, metallurgy, battery industry workers)\n* Pregnancy or breastfeeding\n* History of acute infection or inflammatory disease\n* History of recurrent surgery or advanced metastatic cancer (as this may alter serum parameters)\n* Psychiatric or cognitive disorders that preclude participation in the study"}, 'identificationModule': {'nctId': 'NCT07210918', 'briefTitle': 'Serum Trace Element Levels in Some Gynecological Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Serum Trace Element Profiles in Women With Endometriosis, Ovarian and Endometrial Cancer: An ICP-MS-Based Comparative Study', 'orgStudyIdInfo': {'id': 'Cütam Dilara'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Consists of healthy individuals', 'interventionNames': ['Diagnostic Test: Blood Product']}, {'type': 'EXPERIMENTAL', 'label': 'Endometriosis group', 'description': 'Consists of individuals diagnosed with endometriosis', 'interventionNames': ['Diagnostic Test: Blood Product']}, {'type': 'EXPERIMENTAL', 'label': 'Overian cancer group', 'description': 'Consists of individuals diagnosed with ovarian cancer', 'interventionNames': ['Diagnostic Test: Blood Product']}, {'type': 'EXPERIMENTAL', 'label': 'Endometrial cancer', 'description': 'Consists of individuals diagnosed with endometrial cancer', 'interventionNames': ['Diagnostic Test: Blood Product']}], 'interventions': [{'name': 'Blood Product', 'type': 'DIAGNOSTIC_TEST', 'description': '5 mL of blood was collected from the right arms of all individuals in 4 different groups. Their serum was obtained.', 'armGroupLabels': ['Control group', 'Endometrial cancer', 'Endometriosis group', 'Overian cancer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58146', 'city': 'Sivas', 'state': 'Centre', 'country': 'Turkey (Türkiye)', 'facility': 'sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dilara Ulger Ozbek', 'investigatorAffiliation': 'Cumhuriyet University'}}}}