Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT03161704
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Collection of Plasma in 1 4ml EDTA tube', 'timeFrame': '3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.', 'description': '1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection.'}, {'measure': 'Collection of Whole Blood in 2 4ml EDTA tubes', 'timeFrame': '3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.', 'description': '2 4ml EDTA tubes will be drawn at each collection, up to 2 4.5ml aliquots as well as 1 FTA blood spot collection card per collection.'}, {'measure': 'Collection of Urine will be one complete sample as produced by the subject', 'timeFrame': '3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.', 'description': '1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken.'}], 'primaryOutcomes': [{'measure': 'Collection of up to 3 2cm samples of Endometrial Tissue', 'timeFrame': '2 collection timepoints: baseline and up to 18 weeks following surgery.', 'description': 'Up to 3 2cm samples will be collected per collection.'}], 'secondaryOutcomes': [{'measure': 'Collection of Serum 1 will be 2 10ml serum tubes of serum', 'timeFrame': '3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.', 'description': '2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.'}, {'measure': 'Collection of Serum 2 will be 2 7 ml serum tubes of serum', 'timeFrame': '3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.', 'description': '2 7ml serum tubes drawn at each collection, up to 10 1.0ml aliquots of serum plus 1 15ml conical tube with the 2 blood clots per collection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy). Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* • Currently pregnant\n\n * Current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer)\n * Known to be HIV-positive\n * Unable to give informed consent\n * Unwillingness to have samples banked in Repository for future use\n * Clinical evidence of active cervical infection\n * Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron within the last 4 months)\n * Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).\n\n o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).\n * Use of depo estrogen or progestin in last 3 months\n * Current use of aromatase inhibitor\n\nInclusion Criteria:\n\n* Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).\n\nIndication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.'}, 'identificationModule': {'nctId': 'NCT03161704', 'briefTitle': 'Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol', 'orgStudyIdInfo': {'id': 'ENDOmarker'}}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kurt Barnhart, MD MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Esther Eisenberg, MD MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, {'name': 'Nanette Santoro, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Michael Diamond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}, {'name': 'Richard Legro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}, {'name': 'Marcelle Cedars, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Anne Steiner, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Karl Hansen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}, {'name': 'Christos Coutifaris, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Heping Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Augusta University', 'class': 'OTHER'}, {'name': 'Penn State University', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}