Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT04974567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2021-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tear Based Sample Collection Breast Cancer Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-13', 'size': 349689, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-06T12:18', 'hasProtocol': True}, {'date': '2021-04-28', 'size': 153831, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-06T12:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Lacrimal (tear) fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participant tear samples collected.', 'timeFrame': '90 days', 'description': 'The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preventative screening', 'protein biomarkers', 'lacrimal tear fluid', 'mammography', 'ELISA assay', 'CLIA laboratory', 'lab developed test', 'high complexity', 'tear collection', 'mammogram', 'improved patient outcomes', 'reduce gap in access', 'health equity', 'total cost of care', 'trust from patient', 'increased compliance', 'affordable', 'low cost', 'non-invasive', "women's health and wellness", 'breast health', 'breast cancer screening test'], 'conditions': ['Breast Cancer', 'Tear', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.', 'detailedDescription': 'Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Tear Based Breast Cancer Detection study participants are all women, born biologically female, with a recent diagnosis of breast cancer, have not started treatment, and are between the ages of 18 to 100 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual is an adult woman and has recently been diagnosed with breast cancer.\n\nExclusion Criteria:\n\n* Individual is excluded if they have already started treatment for the breast cancer diagnosis.\n* Age less than 18 or more than 100 years.'}, 'identificationModule': {'nctId': 'NCT04974567', 'briefTitle': 'Tear Based Sample Collection Breast Cancer Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Namida Lab'}, 'officialTitle': 'Tear Based Sample Collection for Breast Cancer Detection', 'orgStudyIdInfo': {'id': 'IRB # 21-0026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women recently diagnosed with breast cancer who have not undergone any treatment.', 'description': 'Tear sample collection', 'interventionNames': ['Other: Schirmer Strip']}], 'interventions': [{'name': 'Schirmer Strip', 'type': 'OTHER', 'description': 'A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.', 'armGroupLabels': ['Women recently diagnosed with breast cancer who have not undergone any treatment.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0737', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB Health', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Suzanne Klimberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared or made available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namida Lab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}