Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04074720
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2019-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Breast Cancer Biospecimen Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor and normal adjacent tissue samples will be collected from approximately 200 living patients with breast cancer irrespective of hormone status under the care of TJUH clinicians. Serum will be collected at the same time as serum and adjacent normal so that serum exosomes as well as extracellular matrix influences can be examined.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor biomarker identification', 'timeFrame': 'Up to 5 years', 'description': 'Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).'}], 'secondaryOutcomes': [{'measure': 'Laboratory-based breast cancer tumor genomic profile', 'timeFrame': 'Up to 5 years', 'description': 'Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Tumor Tissue Collection', 'Serum Collection', 'Plasma Collection', 'Fresh Tissue Collection', 'Fixed Tissue Collection', 'Translational Research', 'Biospecimen Collection', 'Surgical Resection', 'Vascular Access Placement'], 'conditions': ['Breast Cancer', 'Invasive Breast Cancer', 'Carcinoma in Situ of the Breast']}, 'descriptionModule': {'briefSummary': 'Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death', 'detailedDescription': 'This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years old at time of consent\n* Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.\n* Patients with carcinoma in situ or invasive breast cancer\n* Patient must be undergoing one of the following:\n\n * definitive surgical tumor resection for breast cancer OR\n * placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR\n * neurosurgical resection of a brain metastasis from primary breast cancer.\n\nExclusion Criteria:\n\n* \\<18 years old\n* Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.\n* Active drug/alcohol dependence or abuse history'}, 'identificationModule': {'nctId': 'NCT04074720', 'briefTitle': 'Prospective Breast Cancer Biospecimen Collection', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Prospective Breast Cancer Biospecimen Collection', 'orgStudyIdInfo': {'id': '16D.674'}, 'secondaryIdInfos': [{'id': 'JT 8877', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Newly Diagnosed Breast Cancer Patients', 'description': 'Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.', 'interventionNames': ['Procedure: Tissue Sample collection', 'Other: Blood Sample Collection', 'Other: Rectal Swab']}, {'label': 'Group 2: Patients with Brain Metastases from Primary Breast Cancer', 'description': 'The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.', 'interventionNames': ['Procedure: Tissue Sample collection', 'Other: Blood Sample Collection', 'Other: Rectal Swab']}], 'interventions': [{'name': 'Tissue Sample collection', 'type': 'PROCEDURE', 'description': 'Tissue sample collected following standard of care procedure patient was already scheduled to have', 'armGroupLabels': ['Group 1: Newly Diagnosed Breast Cancer Patients', 'Group 2: Patients with Brain Metastases from Primary Breast Cancer']}, {'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'A one time sample of blood will be collected on day of standard of care procedure', 'armGroupLabels': ['Group 1: Newly Diagnosed Breast Cancer Patients', 'Group 2: Patients with Brain Metastases from Primary Breast Cancer']}, {'name': 'Rectal Swab', 'type': 'OTHER', 'description': 'optional rectal swab may be collected on day of standard of care procedure', 'armGroupLabels': ['Group 1: Newly Diagnosed Breast Cancer Patients', 'Group 2: Patients with Brain Metastases from Primary Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Simone', 'role': 'CONTACT', 'email': 'Nicole.Simone@jefferson.edu', 'phone': '2159556702'}], 'facility': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Nicole Simone, MD', 'role': 'CONTACT', 'email': 'Nicole.Simone@jefferson.edu', 'phone': '215-955-6702'}], 'overallOfficials': [{'name': 'Nicole Simone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}