Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 12:10 PM
Study NCT ID:
NCT03631667
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultralow Dose PAH Binary Mixture Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031181', 'term': 'phenanthrene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.williams@oregonstate.edu', 'phone': '541-737-3277', 'title': 'David E. Williams, PhD', 'organization': 'Oregon State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48.5 hours for each of 2 dosing cycles with a 3-week washout period between the dosing cycles. Participants were assessed for adverse events 15 minutes prior to the [14c]-BaP dose administration (time= 0 hour) until 15 minutes after the final blood sample collection time point (time = 48 hour) and removal of the peripheral IV catheter.', 'description': 'The definitions of adverse event and serious adverse event used to determine incidence are consistent with clinicaltrials.gov definitions. Each participant was verbally asked about the occurrence of adverse events at each clinical visit by the research nurse.', 'eventGroups': [{'id': 'EG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration of 14C-BaP Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Cycle 1: Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP).\n\nCycle 2: Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene.\n\nAt least 3 weeks will pass between cycles as a washout period.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'classes': [{'title': '50 ng [14C]-BaP', 'categories': [{'measurements': [{'value': '7.07', 'spread': '4.89', 'groupId': 'OG000'}]}]}, {'title': '50 ng [14C]-BaP plus 1250 ng phenanthrene', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of highest concentration of 14C-BaP in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Cmax.', 'unitOfMeasure': 'fg [14C]-BaP/mL plasma', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time at Highest Plasma Concentration of 14C-BaP Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'classes': [{'title': '50 ng [14C]-BaP', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '50 ng [14C]-BaP plus 1250 ng phenanthrene', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of time at which plasma concentration of 14C-BaP is highest. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Tmax.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'classes': [{'title': '50 ng [14C]-BaP', 'categories': [{'measurements': [{'value': '17.88', 'spread': '9.56', 'groupId': 'OG000'}]}]}, {'title': '50 ng [14C]-BaP plus 1250 ng phenanthrene', 'categories': [{'measurements': [{'value': '10.07', 'spread': '9.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Integration of concentration of 14C-BaP in plasma over time. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine AUC.', 'unitOfMeasure': 'fg [14C]-BaP/mL plasma x hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Elimination of 14C-BaP (Half Life)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'classes': [{'title': '50 ng [14C]-BaP', 'categories': [{'measurements': [{'value': '4.78', 'spread': '4.45', 'groupId': 'OG000'}]}]}, {'title': '50 ng [14C]-BaP plus 1250 ng phenanthrene', 'categories': [{'measurements': [{'value': '3.92', 'spread': '4.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of constants for rate of elimination of 14C-BaP from plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine half-life.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '8 participants consented to participate. 3 participants voluntarily withdrew prior to beginning the study protocol (no BaP doses administered).', 'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene', 'description': 'Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.\n\n\\[14C\\]-benzo\\[a\\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)\n\n\\[14C\\]-benzo\\[a\\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-22', 'size': 1271132, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-07T17:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Deidentified samples will be analyzed by AMS at Lawrence Livermore National Laboratory and the pharmacokinetics determine at Pacific Northwest National Laboratory.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2018-08-08', 'resultsFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration of 14C-BaP Cmax', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of highest concentration of 14C-BaP in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Cmax.'}, {'measure': 'Time at Highest Plasma Concentration of 14C-BaP Tmax', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of time at which plasma concentration of 14C-BaP is highest. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Tmax.'}], 'secondaryOutcomes': [{'measure': 'Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Integration of concentration of 14C-BaP in plasma over time. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine AUC.'}, {'measure': 'Rate of Elimination of 14C-BaP (Half Life)', 'timeFrame': '0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles', 'description': 'Determination of constants for rate of elimination of 14C-BaP from plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine half-life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzo[a]pyrene', 'Accelerator Mass Spectrometry', 'Polycyclic Aromatic Hydrocarbons', 'Phenanthrene'], 'conditions': ['Environmental Exposure']}, 'descriptionModule': {'briefSummary': 'Evaluation of the pharmacokinetics for \\[14C\\]-benzo\\[a\\]pyrene (\\[14C\\]-BaP) and metabolites in plasma and urine over 48 hours following a 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene.', 'detailedDescription': 'The pharmacokinetics for \\[14C\\]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over 48 hours following oral doses of 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene. Metabolite profiles and kinetics of elimination are predicted to be consistent with a BaP physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de minimus risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 21-65 (inclusive)\n* If female, must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure\n* Willing to defer blood donation for one month before, throughout, and one month after completion of study activities\n* Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)\n\nExclusion Criteria:\n\n* Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker\n* Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)\n* History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)\n* Current or history of kidney or liver disease\n* Prior high-dose 14C exposure from medical tests. (micro-dose 14C exposure not exclusionary)\n* Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)\n* Regular use of indole-3-carbinol or DIM dietary supplements"}, 'identificationModule': {'nctId': 'NCT03631667', 'briefTitle': 'Ultralow Dose PAH Binary Mixture Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon State University'}, 'officialTitle': 'Ultralow Dose PAH Binary Mixture Study', 'orgStudyIdInfo': {'id': 'LPI-8554'}, 'secondaryIdInfos': [{'id': 'R01ES028600', 'link': 'https://reporter.nih.gov/quickSearch/R01ES028600', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 ng dose and 50 ng dose plus 1250 ng phenanthrene', 'description': 'Cycle 1: Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP).\n\nCycle 2: Capsule containing 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene (BaP) and 1250 phenanthrene.\n\nAt least 3 weeks will pass between cycles as a washout period.', 'interventionNames': ['Drug: [14C]-benzo[a]pyrene', 'Drug: [14C]-benzo[a]pyrene plus phenanthrene']}], 'interventions': [{'name': '[14C]-benzo[a]pyrene', 'type': 'DRUG', 'otherNames': ['Carcinogenic PAH environmental pollutant'], 'description': 'Oral micro-dose (50 ng) (5.4 nCi)', 'armGroupLabels': ['50 ng dose and 50 ng dose plus 1250 ng phenanthrene']}, {'name': '[14C]-benzo[a]pyrene plus phenanthrene', 'type': 'DRUG', 'otherNames': ['Binary mixture of carcinogenic PAH and non-carcinogenic PAH'], 'description': 'Oral micro-dose of 50 ng (5.4 nCi) \\[14C\\]-benzo\\[a\\]pyrene plus 1250 ng phenanthrene', 'armGroupLabels': ['50 ng dose and 50 ng dose plus 1250 ng phenanthrene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97331', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon State University', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified samples sent to Lawrence Livermore National Laboratory Deidentified data sent to Pacific Northwest National Laboratory'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}, {'name': 'Lawrence Livermore National Laboratory', 'class': 'OTHER'}, {'name': 'Pacific Northwest National Laboratory', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Williams', 'investigatorAffiliation': 'Oregon State University'}}}}