Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-06 @ 9:42 PM
Study NCT ID:
NCT02370303
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2015-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Preoperative blood sample, tumor tissue from lung resection, postoperative blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and types of mutations in the primary tumor.', 'timeFrame': 'Within 1 year'}, {'measure': 'Number and type of mutations detectable in the matched circulating tumor cell samples.', 'timeFrame': 'Within 1 year'}], 'secondaryOutcomes': [{'measure': 'Concordance of mutations detected by either method.', 'timeFrame': 'Within 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Lung Neoplasms', 'Cancer of Lung', 'Cancer of the Lung', 'Neoplasms, Lung', 'Neoplasms, Pulmonary', 'Pulmonary Cancer', 'Pulmonary Neoplasms', 'Carcinoma, Non-small-cell Lung', 'Adenocarcinoma', 'Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.', 'detailedDescription': "The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IB and above non-small cell lung cancer or metastatic lung cancer\n* Age \\>18 years old\n* Willing and able to consent to study\n* No prior history of neoadjuvant therapy.\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT02370303', 'briefTitle': 'A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System', 'orgStudyIdInfo': {'id': '14-003962'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Dennis Wigle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clearbridge Biomedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Dennis Wigle', 'investigatorAffiliation': 'Mayo Clinic'}}}}