Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT00015561
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2001-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pesticides--Health Fertility and Reproductive Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 1803}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2001-08'}, 'lastUpdateSubmitDate': '2006-09-01', 'studyFirstSubmitDate': '2001-04-20', 'studyFirstSubmitQcDate': '2001-04-21', 'lastUpdatePostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-04-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['population studies', 'laboratory evaluation', 'hormone analysis', 'semen analysis', 'chromosome studies'], 'conditions': ['Birth Defects', 'Miscarriages', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '10945240', 'type': 'BACKGROUND', 'citation': 'Lyubimov AV, Garry VF, Carlson RE, Barr DB, Baker SE. Simplified urinary immunoassay for 2,4-D: validation and exposure assessment. J Lab Clin Med. 2000 Aug;136(2):116-24. doi: 10.1067/mlc.2000.108150.'}, {'pmid': '10933758', 'type': 'BACKGROUND', 'citation': 'Lin N, Garry VF. In vitro studies of cellular and molecular developmental toxicity of adjuvants, herbicides, and fungicides commonly used in Red River Valley, Minnesota. J Toxicol Environ Health A. 2000 Jul 28;60(6):423-39. doi: 10.1080/00984100050033494.'}, {'pmid': '10931789', 'type': 'BACKGROUND', 'citation': 'Kirkhorn SR, Garry VF. Agricultural lung diseases. Environ Health Perspect. 2000 Aug;108 Suppl 4(Suppl 4):705-12. doi: 10.1289/ehp.00108s4705.'}, {'pmid': '10188198', 'type': 'BACKGROUND', 'citation': 'Garry VF, Burroughs B, Tarone R, Kesner JS. Herbicides and adjuvants: an evolving view. Toxicol Ind Health. 1999 Jan-Mar;15(1-2):159-67. doi: 10.1191/074823399678846619.'}, {'pmid': '10064550', 'type': 'BACKGROUND', 'citation': 'Schreinemachers DM, Creason JP, Garry VF. Cancer mortality in agricultural regions of Minnesota. Environ Health Perspect. 1999 Mar;107(3):205-11. doi: 10.1289/ehp.99107205.'}]}, 'descriptionModule': {'briefSummary': 'This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Pesticide applicators and their spouses'}, 'identificationModule': {'nctId': 'NCT00015561', 'briefTitle': 'Pesticides--Health Fertility and Reproductive Risk', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Environmental Health Sciences (NIEHS)'}, 'orgStudyIdInfo': {'id': '8161-CP-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical School', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Vincent F Garry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}}}}