Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-17 @ 2:04 AM
Study NCT ID:
NCT06907550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of endometriosis', 'timeFrame': 'up to 5 years', 'description': 'Presence or absence of endometriosis as determined by standard-of-care diagnostic laparoscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. This study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the MET to be run.\n\nThis study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an LDT. Following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Females between menarche and menopause presenting with symptoms suggestive of endometriosis and scheduled for a standard-of-care diagnostic laparoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis\n2. Provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics)\n3. Be fit to undergo all procedures listed in protocol\n4. Be able to provide written informed consent\n\nExclusion Criteria:\n\n1. Has had a prior surgical diagnosis of endometriosis at time of blood collection\n2. Is unable to communicate in written and spoken English\n3. Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. This reason must be recorded on the CRF'}, 'identificationModule': {'nctId': 'NCT06907550', 'briefTitle': 'Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearsanta, Inc'}, 'officialTitle': 'Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis', 'orgStudyIdInfo': {'id': 'R2025-1001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females suspected of endometriosis scheduled for laparoscopic surgery', 'description': 'Females suspected of endometriosis scheduled for laparoscopic surgery', 'interventionNames': ['Diagnostic Test: The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis']}], 'interventions': [{'name': 'The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for testing.', 'armGroupLabels': ['Females suspected of endometriosis scheduled for laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': 'Stephen Varvel', 'role': 'CONTACT', 'email': 'svarvel@pearsanta.com', 'phone': '8048364439'}], 'facility': 'Pearsanta, Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Stephen A Varvel, Ph.D.', 'role': 'CONTACT', 'email': 'svarvel@pearsanta.com', 'phone': '18048364439'}], 'overallOfficials': [{'name': 'Stephen A Varvel, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pearsanta, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearsanta, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}