Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-09 @ 2:22 AM
Study NCT ID:
NCT02934360
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TR(ACE) Assay Clinical Specimen Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma specimens will be collected prospective and tested retrospectively'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment change', 'timeFrame': 'Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months', 'description': "Standard of care physician's clinical assessment of disease progression or response compared to previous visit"}], 'secondaryOutcomes': [{'measure': 'RECIST 1.1 criteria', 'timeFrame': 'Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months', 'description': 'RECIST 1.1 criteria of subjects from current to previous visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Breast Cancer', 'cell free DNA', 'biomarker'], 'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.', 'detailedDescription': 'This study is to establish the clinical performance of the TR(ACE) Assay. Deltas of serial TR(ACE) Assay measurements will be compared to the standard of care physician clinical assessment and RECIST 1.1 criteria evaluation relative to the previous visit. Significant changes in serial TR(ACE) Assay measurements are hypothesized to correlate with disease progression or response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Previously diagnosed non-small cell lung cancer subjects undergoing standard of care treatment Previously diagnosed breast cancer subjects undergoing standard of care treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small cell lung: Male or Female Adult patient \\>= 21 years old\n* Breast only: Female Adult patient \\>= 21 years old\n* Previously diagnosed with one of the following cancers:\n\nBreast or Non-small Cell Lung\n\n* Cancer has progressed to at least Stage III or higher for lung cancer or,\n* Cancer has progressed to stage IV (metastatic) breast cancer\n* Participating in standard of care cancer therapy requiring frequent treatments, typically intravenous chemotherapy visits (or as determined by the standard of care for the particular cancer assessed), of a minimum of three (3) treatment visits planned in 9 months from date of enrollment where a clinical assessment will be conducted\n\nExclusion Criteria:\n\n* Physician assessment that obtaining two extra whole blood specimens with minimum volume of 5 mL per treatment visit is contraindicated\n* Stage I and II Non-small Cell Lung Cancer\n* Stage I through III breast cancer\n* Pregnant or planning to become pregnant during the course of the study\n* Unable to obtain informed consent from subject or their legal representative\n* Life expectancy is less than 9 months\n* Presence of one or more of the following other chronic diseases\n* Another type of cancer except for non-melanomatous skin tumors\n* Autoimmune disease requiring DMARDS or Biologics\n* Infectious disease requiring prolonged intravenous antibiotics or hospitalization\n* Renal disease specifically those in End Stage Renal Failure\n* Recent (\\< 3 weeks) major trauma or major surgical procedure(s) or radiation therapy prior to enrollment in the study\n* Recent (\\< 2 months) major occlusive arterial event such as MI or CVA prior to enrollment in the study'}, 'identificationModule': {'nctId': 'NCT02934360', 'briefTitle': 'TR(ACE) Assay Clinical Specimen Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biological Dynamics'}, 'officialTitle': 'Evaluation of the TR(ACE) Assay for the Ability to Aid in Monitoring Disease Progress, Response to Therapy or for Recurrent or Residual Disease for Patients With Previously Diagnosed Cancers (Stage III and IV Lung and Stage IV Breast)', 'orgStudyIdInfo': {'id': 'BioDyn-15-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-small cell Lung Cancer', 'description': 'Previously diagnosed stage III or higher non-small cell lung cancer subjects will provide serial plasma specimens and clinical assessment information over time', 'interventionNames': ['Device: TR(ACE) Assay Testing']}, {'label': 'Breast Cancer', 'description': 'Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time.', 'interventionNames': ['Device: TR(ACE) Assay Testing']}], 'interventions': [{'name': 'TR(ACE) Assay Testing', 'type': 'DEVICE', 'description': 'Serial plasma testing with TR(ACE) Assay', 'armGroupLabels': ['Breast Cancer', 'Non-small cell Lung Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanna Garcia', 'role': 'CONTACT', 'phone': '760-452-3909'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '480-735-9035'}], 'facility': 'California Cancer Associates for Reseach and Excellence, Inc. (cCare)', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yumiko Kawai', 'role': 'CONTACT', 'phone': '760-758-5770'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '480-735-9035'}], 'facility': 'North County Oncology Medical Inc. (North County)', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Osita Onugha, MD', 'role': 'CONTACT', 'email': 'osita.onugha@providence.org', 'phone': '310-829-8618'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Osita Onugha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prutha Patel', 'role': 'CONTACT', 'email': 'prutha@clorene.org', 'phone': '407-921-3767'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '480-735-9035'}], 'facility': 'Mid-Florida', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nikki Branca', 'role': 'CONTACT', 'email': 'nbranca@bondclinic.com', 'phone': '863-293-1191'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Osama Abu Hlalah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bond Clinic', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Peabody', 'role': 'CONTACT', 'email': 'blm-clinicalresearch@iuhealth.org', 'phone': '812-353-2831'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Jeffery Allerton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Health Bloomington', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '41101', 'city': 'Ashland', 'state': 'Kentucky', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Ashland Bellefonte Cancer Center', 'geoPoint': {'lat': 38.47841, 'lon': -82.63794}}, {'zip': '48060', 'city': 'Port Huron', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Fisher, RN', 'role': 'CONTACT', 'email': 'kfisher2@primehealthcare.com', 'phone': '810-216-1185'}, {'name': 'Robert Langolf', 'role': 'CONTACT', 'email': 'robert.langolf@michmer.com', 'phone': '248-747-4383'}, {'name': 'Anup Lal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michmer (Lake Huron Medical Center)', 'geoPoint': {'lat': 42.97086, 'lon': -82.42491}}, {'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlyn Singer', 'role': 'CONTACT', 'email': 'ksinger@hhsnj.org', 'phone': '908-237-2330', 'phoneExt': '3'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Waqas Rehman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunterdon Hematology Oncology', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan A Gapilango, RN MSN OCN CCRP', 'role': 'CONTACT', 'email': 'jonathan.gapilango@rwjbh.org', 'phone': '732-557-8239'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '240-415-6022'}], 'facility': 'Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Don Marx', 'role': 'CONTACT', 'email': 'dmarx@nycancer.com', 'phone': '631-675-5143'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'David Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Shore Hematology Oncology', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carrie Smith', 'role': 'CONTACT', 'email': 'csmith@gabrailcancercenter.com', 'phone': '330-492-3345'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Nashat Gabrail, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joann Ackler', 'role': 'CONTACT', 'email': 'acklerj@einstein.edu', 'phone': '215-456-8295'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'William Tester, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albert Einstein Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29621', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'AnMed Health Oncology Research Office', 'role': 'CONTACT', 'phone': '864-512-4650'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'John E Doster, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AnMed', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Krista Tibbs', 'role': 'CONTACT', 'email': 'ktibbs@biomed-research.com', 'phone': '865-934-2676'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Tracy Dobbs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tennessee Cancer Specialists', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Perla Lopez', 'role': 'CONTACT', 'email': 'plopez@hopecancertexas.com', 'phone': '903-595-7041'}, {'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Arielle Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tyler Hematology Oncology', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'centralContacts': [{'name': 'Patsy Folio', 'role': 'CONTACT', 'email': 'patsy.folio@precisionformedicine.com', 'phone': '1-240-415-6022'}, {'name': 'Transis Clemons', 'role': 'CONTACT', 'email': 'transis.clemons@precisionformedicine.com', 'phone': '1-240-415-6038'}], 'overallOfficials': [{'name': 'Robert Kovelman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biological Dynamics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Following direct de novo submission, data will be summarized in decision summary and package insert'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biological Dynamics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}