Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06460818
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Sample Collection- Sampling During Uterine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'fresh and frozen tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with optimal vaginal samples obtained during the collection process', 'timeFrame': '9 months', 'description': 'Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Women's Health"]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing hysterectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.\n2. Willing and able to comply with scheduled visits, investigational plan, and other procedures.\n3. Females:\n\n 1. Aged \\>45 for benign and pre-malignant cases\n 2. Aged \\>18 with positive biopsies.\n4. Presence of uterus.\n5. Scheduled for hysterectomy.\n\nExclusion Criteria:\n\n1. Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.\n2. Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.\n3. Women who have undergone a hysterectomy.\n4. Inability or unwillingness to sign informed consent.\n5. Contraindication to surgery, including pregnancy.\n6. Women who have used a tampon within 7 days of surgery.'}, 'identificationModule': {'nctId': 'NCT06460818', 'briefTitle': 'Surgical Sample Collection- Sampling During Uterine Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'PinkDx, Inc.'}, 'officialTitle': 'Surgical Sample Collection- Sampling During Uterine Surgery', 'orgStudyIdInfo': {'id': 'PNK001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'benign', 'description': 'tissue collection from women with benign reproductive conditions'}, {'label': 'malignant', 'description': 'tissue collection from women with suspected and malignant reproductive conditions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Andrea Mariani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PinkDx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}