Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT01707758
Status:
WITHDRAWN
Last Update Posted:
2013-05-16
First Post:
2012-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Approximately 1 tablespoon of blood will be collected from each subject.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Trial terminated - Nanoscale Company out of business', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'nanoparticle', 'proteases', 'cell survival', 'tumor progression', 'angiogenesis', 'tissue remodeling/invasion'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.', 'detailedDescription': 'The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from the University of Kansas Cancer Center prior to any treatment for their pancreatic cancer. Final histology and staging will be recorded and correlated with protease concnentration. Healthy subjects will be recruited from the University of Kansas and Kansas State community.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria for Pancreatic Cancer Patients:\n\n* Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.\n* Patients will have had no prior treatment or surgery\n\nInclusion Criteria for Healthy Subjects:\n\n* Subjects will have no prior history of any cancer\n\nExclusion Criteria:\n\nExclusion Criteria for Pancreatic Cancer Patients\n\n* Any prior treatment for pancreatic cancer\n* Poorly controlled diabetes\n\nExclusion Criteria for Healthy Subjects\n\n* Poorly controlled diabetes'}, 'identificationModule': {'nctId': 'NCT01707758', 'briefTitle': 'Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence', 'orgStudyIdInfo': {'id': '13421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pancreatic cancer', 'description': 'This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephen Williamson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}