Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-03 @ 5:09 PM
Study NCT ID:
NCT03633006
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Residual blood samples may be used for further analysis and future research. Samples may be stored for up to 20 years. These blood samples will be de-identified.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3298}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker Identification', 'timeFrame': 'Subjects could be followed for up to 27 months.', 'description': 'Screening subjects to find the appropriate methylation sites for the detection of lung cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.', 'detailedDescription': 'Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 3,250 subjects will be enrolled in this study. Subjects will be men and women, 35 years of age or older, with a CT confirmed nodule measuring 6-30 mm. Subjects will be enrolled into one of three groups: CT suspicion of lung cancer who are scheduled for biopsy/other diagnostic procedure; pathologically confirmed lung cancer that are treatment naïve; or recent positive CT showing pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Subjects:\n\n 1. Subject is male or female, 35 years of age or older.\n 2. Subject has at least one CT confirmed 6-30 mm nodule.\n 3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.\n\n Suspicion of Cancer Subjects:\n 4. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.\n\nPathologically Confirmed Cancer Subjects:\n\n4\\. Subject has pathologically confirmed lung cancer and is treatment naïve.\n\nPulmonary Nodule Subjects:\n\n4\\. Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT).\n\nExclusion Criteria:\n\n* All Subjects\n\n 1. CT with IV contrast within 1 day \\[or 24 hours\\] of blood collection.\n 2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment.\n 3. Prior removal of the lung, excluding percutaneous lung biopsy.\n 4. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.\n 5. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.\n\n Pathologically Confirmed Cancer Subjects:\n 6. Biopsy within 7 days prior to blood collection.\n 7. Unresolved bleeding as a result of biopsy at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT03633006', 'briefTitle': 'Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exact Sciences Corporation'}, 'officialTitle': 'Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer', 'orgStudyIdInfo': {'id': '2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Nodules', 'description': 'Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution.\n\nA second blood draw will be collected at 12 months.', 'interventionNames': ['Other: Blood Sample Collection']}, {'label': 'CT Suspicion of Cancer', 'description': 'Subject with suspicion of lung cancer will provide a blood sample.\n\nDiagnostic information will be collected to confirm the final diagnosis.', 'interventionNames': ['Other: Blood Sample Collection']}, {'label': 'Pathologically Confirmed Cancer', 'description': 'Subject has pathologically confirmed lung cancer and is treatment naïve.\n\nSubject will be enrolled and provide a blood sample.', 'interventionNames': ['Other: Blood Sample Collection']}], 'interventions': [{'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.', 'armGroupLabels': ['Pulmonary Nodules']}, {'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.', 'armGroupLabels': ['CT Suspicion of Cancer']}, {'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Subjects participating in the study will have blood drawn at enrollment.', 'armGroupLabels': ['Pathologically Confirmed Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Medical Group', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport NativeMD', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research, Inc', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Veterans Health Care', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Premier Medical Group', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'American Research Institute, Inc', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'International Research Partners, LLC', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Disease Specialists', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research of Central Florida, LLC', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Future Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Orcinova AMS Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Research Institute, Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'American Research Medical Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Health and Life Research Institute, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Care Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trials of Florida, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33169', 'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'AMPM research Clinic', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Hospital Clinical Research Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33704', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Pulmonary and Critical Care, PLC', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasadena Center for Medical Research, Inc', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Pulmonary Research Institute, LLC', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Care Research Group, PA', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Healthcare, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30519', 'city': 'Buford', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Research institute, LLC', 'geoPoint': {'lat': 34.12066, 'lon': -84.00435}}, {'zip': '60631', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Research Institute', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Biomedical Research', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'DC Research Work', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '31326', 'city': 'Rincon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Lung Associates Research', 'geoPoint': {'lat': 32.29603, 'lon': -81.23539}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saltzer Medical Group', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'PMG Research of Christie Clinic', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60631', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Medical and Procedural Specialists of Illinois, LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46011', 'city': 'Anderson', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hospital of Anderson and Madison County, Inc.', 'geoPoint': {'lat': 40.10532, 'lon': -85.68025}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC-An AMR Company', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21742', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Meritus Center for Clinical Research', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '20636', 'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Shah Medical Group', 'geoPoint': {'lat': 39.07511, 'lon': -76.5858}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic, Inc', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton-Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Somnos Laboratories', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Health, Inc', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pulmonary Ultimate Research Experience, LLC (PURE, LLC)', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College MC-91', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11418', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Jamaica Hospital Medical Center', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'American Health Research, LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research of Gastonia', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Gastonia Pharmaceutical Research', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pulmonix, LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hickory Research Center DBA Research Carolina of Hickory', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Health Care', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27804', 'city': 'Rocky Mount', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Rocky Mount, LLC', 'geoPoint': {'lat': 35.93821, 'lon': -77.79053}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington, LLC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45150', 'city': 'Milford', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Trial Developers, Inc.', 'geoPoint': {'lat': 39.17534, 'lon': -84.29438}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research, LLC', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97220', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Oregon Clinic, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16508', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chest Diseases of Northwestern PA', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Protocol Management Specialists', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Safe Harbor Clinical Research', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Anderson Pharmaceutical Research, LLC', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charletson Research Institute', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29340', 'city': 'Gaffney', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)', 'geoPoint': {'lat': 35.07179, 'lon': -81.64982}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research of Charleston', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research of Rock HIll', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research-Rock Hill', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Pharmaceutical Research, LLC', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Union Pharmaceutical Research', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '77429', 'city': 'Cypress', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Pulmonary Sleep and Allergy Associates', 'geoPoint': {'lat': 29.96911, 'lon': -95.69717}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78041', 'city': 'Laredo', 'state': 'Texas', 'country': 'United States', 'facility': 'Envision Cancer Care, LLC', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical Consultants, LLC', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pulmonary Associates of Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital Medical Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'William S. Middleton Memorial Veterans Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Laura Strong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Exact Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form, and clinical study report will also be shared.', 'accessCriteria': 'Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requesors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exact Sciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}