Sponsor study identifier
Secondary identifiers
observational
300
1 country
1
Study Start
December 12, 1994
Actual (reported)Primary Completion
August 13, 2007
Actual (reported)Study Completion
April 16, 2020
Actual (reported)In 1976 an accidental explosion in a chemical plant 16 miles north of Milan resulted in contamination of the local population with 2, 3, 7, 8-terachlorodibenzo-para-dioxin (TCDD). There is evidence that TCDD and related phenoxy herbicides act as teratogens, tumor promoters, and carcinogens in experimental animals. In human, TCDD causes chloracne in those exposed. Associations with various cancers have been reported, but the precise role in human toxicity, immune and reproductive dysfunction, and cancer is controversial. The Seveso accident provides a unique opportunity for an epidemiological investigation in that the exposures are the highest recorded in humans, the exposure involves TCDD without other contaminants, and a cohort in the involved and surrounding area has been enumerated. There is inter-individual variation in the action of genes involved in TCDD effect in human cells. The quality of human AH receptor, and the CYP1A1 and arnt genotypes are examples of susceptibility markers that may identify subjects at high risk for TCDD-related disease. A hypothesis that could explain the inconsistent association of TCDD exposure with cancer is that genetic susceptibility may influence which individuals are adversely affected by TCDD exposure. The study is proceeding in three phases. The first is a pilot/validation study that is complete (field activities) and involved 126 subjects. The second is a case-control study of about 100 individuals with chloracne and 100 controls. The field components of phase one and two are complete, and analyses of results are underway. The third and final phase is a planned case-control study of TCDD-related cancers that will include approximately 125 cases and 125 controls. The study includes a questionnaire/interview and a biospecimen collection; 73 ml of blood are obtained from each participant.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 16, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 1994
Actual (reported)June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)August 13, 2007
Actual (reported)April 16, 2020
Actual (reported)To determine the effect of TCDD exposure on human health
Cancer Risk
Ongoing
Individuals exposed to digoxin
Individuals not exposed to digoxin
The study included subjects who were exposed to dioxin and controls not exposed to dioxin.
University of Milan
Milan, Italy
Baccarelli A, Giacomini SM, Corbetta C, Landi MT, Bonzini M, Consonni D, Grillo P, Patterson DG, Pesatori AC, Bertazzi PA. Neonatal thyroid function in Seveso 25 years after maternal exposure to dioxin. PLoS Med. 2008 Jul 29;5(7):e161. doi: 10.1371/journal.pmed.0050161.
Consonni D, Sindaco R, Agnello L, Caporaso NE, Landi MT, Pesatori AC, Bertazzi PA. Plasma levels of dioxins, furans, non-ortho-PCBs, and TEQs in the Seveso population 17 years after the accident. Med Lav. 2012 Jul-Aug;103(4):259-67.
Maria T Landi, M.D.
National Cancer Institute (NCI)
300 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
December 12, 1994
Actual (reported)Contact the study team to confirm eligibility.
McHale CM, Zhang L, Hubbard AE, Zhao X, Baccarelli A, Pesatori AC, Smith MT, Landi MT. Microarray analysis of gene expression in peripheral blood mononuclear cells from dioxin-exposed human subjects. Toxicology. 2007 Jan 5;229(1-2):101-13. doi: 10.1016/j.tox.2006.10.004. Epub 2006 Oct 17.
Primary Completion
August 13, 2007
Actual (reported)Study Completion
April 16, 2020
Actual (reported)Last Updated
April 20, 2020
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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