Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05339451
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2022-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 345}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%', 'timeFrame': 'Preoperative', 'description': 'Blood biomarkers as endometriosis diagnostic tests'}, {'measure': 'Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis.', 'timeFrame': '3-6 months postoperative in the severe/DIE group', 'description': 'Blood biomarkers as a relapse marker'}, {'measure': 'Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%', 'timeFrame': 'Preoperative', 'description': 'Blood biomarkers as endometriosis diagnostic tests'}], 'secondaryOutcomes': [{'measure': 'Quality of life of patients undergoing surgery for DIE', 'timeFrame': 'Preoperative and 3-6 months postoperative in the severe/DIE group', 'description': 'Endometriosis Health Profile 30 Questionnaire'}, {'measure': 'Achieved pregnancy postoperative', 'timeFrame': 'One year postoperative', 'description': 'Positive pregnancy test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'biomarkers'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'Endometriosis is a chronic, benign, estrogen-dependent disease characterized by endometrial tissue that is implanted outside the uterus into the ovaries, intestines, or peritoneum but also outside the pelvis. It is a common disease that affects 7-10% of women around the world. The most common symptoms are pain and infertility. The diagnosis is histological after removal of lesions with laparoscopy (sensitivity 94%, specificity 79%), and treatment is symptomatic.\n\nAt present, there is not a laboratory test that allows early and adequate diagnosis of endometriosis and therefore it can take up to 10 years for a patient to be diagnosed and patients often suffer from the disease.\n\nThe purpose of our study is to investigate biomarkers associated with endometriosis and prove their use in the diagnosis and staging of endometriosis. The biomarkers will be studied even in relationship to clinical manifestations of the disease, as markers of relapse and as fertility markers. Meanwhile, quality of life of patients with advanced stages of endometriosis postoperatively will be studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited in several gynecological clinics around Sweden. A total of 345 women of reproductive age will be included in the study according to the power calculation. 115 patients who are operated on due to deep infiltrating endometriosis or rASRM III-IV in national endometriosis centers in Sweden, 115 patients who are diagnosed during surgery with early-stage endometriosis (rASRM I-II) and 115 patients who are controls, who are operated on for others benign gynecological diseases (fibroids, ovarian cysts, chronic abdominal pain, sterilization) and have no signs of endometriosis perioperatively.', 'healthyVolunteers': True, 'eligibilityCriteria': 'IInclusion Criteria:\n\n* women of reproductive age (18-45) who are operated because of suspected endometriosis (dysmenorrhea, dyspareunia, infertility, etc.) (patient group)\n* women of reproductive age (18-45) who are operated for other benign gynecological causes with laparoscopy (ovarian cysts, sterilization, fibroids, etc.) and are found without macroscopic endometriosis perioperatively and confirmed with blind biopsies (control group\n* talk swedish or english in order to complete questionnaires and give informed consent for their participation in the study.\n\nExclusion Criteria:\n\n* BMI\\> 40\n* postmenopausal women\n* premature ovarian failure\n* pelvic inflammatory disease (PID)\n* current or previous malignancy\n* pregnancy and 6 months postpartum\n* corticosteroids in the last 3 months\n* pituitary, kidney, liver, adrenal disease\n* endometrial hyperplasia or endometrial polyp\n* cardiovascular or systemic inflammatory diseases.'}, 'identificationModule': {'nctId': 'NCT05339451', 'acronym': 'ENDOBIO', 'briefTitle': 'Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)', 'orgStudyIdInfo': {'id': 'K 2022-2797'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe/Deep infiltrating endometriosis', 'description': 'Endometriosis stage III/IV according to rASRM.', 'interventionNames': ['Diagnostic Test: Blood biomarkers']}, {'label': 'Minimal/mild endometriosis', 'description': 'Endometriosis stage I/II according to rASRM', 'interventionNames': ['Diagnostic Test: Blood biomarkers']}, {'label': 'Controls', 'description': 'Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively.', 'interventionNames': ['Diagnostic Test: Blood biomarkers']}], 'interventions': [{'name': 'Blood biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood biomarkers in plasma and serum.', 'armGroupLabels': ['Controls', 'Minimal/mild endometriosis', 'Severe/Deep infiltrating endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'state': 'Huddinge', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anastasia Drakou', 'role': 'CONTACT'}], 'facility': 'Karolinska Universitetssjukhus Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Malin Brunes, PhD', 'role': 'CONTACT'}], 'facility': 'Södersjukhuset Kvinnokliniken', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christine Asciutto, PhD', 'role': 'CONTACT'}], 'facility': 'Akademiska Uppsala', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Anastasia Drakou, MSc', 'role': 'CONTACT', 'email': 'anastasia.drakou@regionstockholm.se', 'phone': '0046 735500118'}, {'name': 'Kenny Rodriguez-Wallberg, Professor', 'role': 'CONTACT', 'email': 'kenny.rodriguez-wallberg@ki.se'}], 'overallOfficials': [{'name': 'Kenny Rodriguez-Wallberg, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Södersjukhuset (Stockholm South General Hospital)', 'class': 'UNKNOWN'}, {'name': 'Akademiska University Hospital, Uppsala, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}