Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-29 @ 2:30 AM
Study NCT ID:
NCT01990651
Status:
UNKNOWN
Last Update Posted:
2013-11-21
First Post:
2013-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Use of CTC in NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-15', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease', 'timeFrame': 'Completed within 6 months of the last sample collected'}, {'measure': 'In Stage I, II or III patients with resectable disease, to obtain preliminary data to assess whether the number of CTC in post operative peripheral blood samples decrease compared with the number of CTC in the pre operative peripheral blood samples', 'timeFrame': 'Measured up to 12 week post op'}, {'measure': 'To obtain preliminary data to assess whether lower numbers of CTC are associated with a reduction in tumor burden (by RECIST criteria) on imaging', 'timeFrame': 'Completed within 6 months of the last sample collected'}, {'measure': 'To obtain preliminary data to assess whether there is a decrease in the number of CTC during treatment with chemotherapy in Stage IV disease', 'timeFrame': 'measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment'}], 'secondaryOutcomes': [{'measure': 'To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease', 'timeFrame': 'Will be assessed for up to 2 years after subjects last visit'}, {'measure': 'To obtain preliminary data on the association of baseline number of CTC and overall survival for patients with all stages of disease', 'timeFrame': 'Will be assessed for up to 2 years after subjects last visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients', 'detailedDescription': "Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.\n\nThe use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor subjects with lung malignancies:\n\n* 18 years of age and older\n* Diagnosis of new or recurrent non-small cell lung cancer\n* Awaiting treatment and follow up\n* Have radiographic measurable metastatic disease that can be followed\n* Be able to sign an IRB approved informed consent form\n* Life expectancy greater than 12 weeks\n\nFor subjects with COPD and without lung malignancies:\n\n* 18 years of age and older\n* Diagnosis of COPD\n* No current or prior malignancies (except squamous or basal cell carcinoma of the skin)\n* Be able to sign an IRB approved informed consent form\n\nFor Healthy Control Subjects (Dry Runs):\n\n* 18 years of age and older\n* Has no current or prior malignancies (except squamous or basal cell carcinoma of the skin)\n* Patients must sign an IRB approved informed consent form\n\nExclusion Criteria:\n\nFor subjects with lung malignancies:\n\n* Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)\n* ECOG performance status of 4\n* Pregnant female (self-reporting)\n* Cognitively Impaired\n* Prisoner\n\nFor subjects with COPD and without lung malignancies and Healthy Controls:\n\n* Any other form of malignancy (except squamous or basal cell carcinoma of the skin)\n* Pregnant female (self reporting)\n* Cognitively impaired\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT01990651', 'briefTitle': 'Study of Use of CTC in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications', 'orgStudyIdInfo': {'id': '15847'}}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Royanne Dell', 'role': 'CONTACT', 'email': 'RLB8Y@virginia.ed', 'phone': '434-924-9496'}, {'name': 'Thao Dang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Royanne Dell', 'role': 'CONTACT', 'email': 'RLB8Y@virginia.edu', 'phone': '434-924-9496'}, {'name': 'Snjezana Zaja-Milatovic', 'role': 'CONTACT', 'email': 'sz7s@virginia.edu', 'phone': '434-243-6575'}], 'overallOfficials': [{'name': 'Thao Dang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}