Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-01-31 @ 6:18 AM
Study NCT ID:
NCT03372902
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 628}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of participants with malignant biopsy', 'timeFrame': '2 years', 'description': 'result of the biopsy of the BIRADS 4 breast'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast imaging', '17-598'], 'conditions': ['Breast Cancer', 'Breast Benign']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females with one or more BI-RADS 4 radiographic lesion who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at a participating study center.', 'genderDescription': 'Breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with one or more BI-RADS 4 radiographic lesions who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at MSKCC or at an MSK Alliance Member Site. If multiple imaging modalities were employed (mammogram, ultrasound, MRI) and no integrated score is provided, then the highest BI-RADS score will be used.\n* Age ≥ 18 years at the time of breast biopsy\n* Willing to provide blood samples for research purposes before biopsy.\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Women with a BI-RADS 4 lesion who had the lesion previously biopsied\n* Females with a current active malignancy other than non-melanoma skin cancers. Females are considered not to have a "current active" malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis\n* Currently pregnant women\n* History of bilateral mastectomy.\n* Participant has or is currently participating in another GRAIL-sponsored protocol'}, 'identificationModule': {'nctId': 'NCT03372902', 'briefTitle': 'Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions', 'orgStudyIdInfo': {'id': '17-598'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal mammograms (BI-RADS 1 or 2)', 'interventionNames': ['Device: Breast MRI', 'Device: Breast Mammogram', 'Other: Blood draw', 'Behavioral: online participant reported questionnaire']}, {'label': 'suspicious lesion group (BI-RADS 4)', 'interventionNames': ['Device: Breast MRI', 'Device: Breast Mammogram', 'Other: Blood draw', 'Procedure: Breast Biopsy', 'Behavioral: online participant reported questionnaire']}], 'interventions': [{'name': 'Breast MRI', 'type': 'DEVICE', 'description': 'Participants with dense breast tissue will get a mammogram and MRI', 'armGroupLabels': ['normal mammograms (BI-RADS 1 or 2)', 'suspicious lesion group (BI-RADS 4)']}, {'name': 'Breast Mammogram', 'type': 'DEVICE', 'description': 'State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.', 'armGroupLabels': ['normal mammograms (BI-RADS 1 or 2)', 'suspicious lesion group (BI-RADS 4)']}, {'name': 'Blood draw', 'type': 'OTHER', 'description': 'Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.', 'armGroupLabels': ['normal mammograms (BI-RADS 1 or 2)', 'suspicious lesion group (BI-RADS 4)']}, {'name': 'Breast Biopsy', 'type': 'PROCEDURE', 'description': 'Tissue specimens from the biopsy of the BI-RADS 4 mammographic lesion and (among women undergoing surgical excision) the surgical specimen(s) will be subjected to genomic profiling at GRAIL, Inc. or MSKCC. The tumor specimens from the participants diagnosed with cancer during the follow-up period will also undergo molecular profiling.', 'armGroupLabels': ['suspicious lesion group (BI-RADS 4)']}, {'name': 'online participant reported questionnaire', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.', 'armGroupLabels': ['normal mammograms (BI-RADS 1 or 2)', 'suspicious lesion group (BI-RADS 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Healthcare Cancer Institute @ Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Alliance MCI', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering at Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Katja Pinker-Domenig, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'GRAIL, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}