Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT02410603
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2015-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
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': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chemotherapy'], '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']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).', 'detailedDescription': "Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced stage cancer in the thorax who are scheduled to undergo systemic therapy at the Mayo Clinic in Rochester, MN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced (non-resectable) malignancy in the thorax\n* Age \\>18 years old\n* Willing and able to provide consent\n* No prior history of neoadjuvant therapy\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Unable to provide consent\n* Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)'}, 'identificationModule': {'nctId': 'NCT02410603', 'briefTitle': 'Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer', 'orgStudyIdInfo': {'id': '15-000373'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Aaron Mansfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Aaron S. Mansfield, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}