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Molecular Epidemiology of Dioxin-Related Illness in Seveso

NCT00340873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-04-20

No results posted yet for this study

Summary

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.

Conditions

  • 2,3,7,8-Tetrachlorodibenzo-Para-Dioxin (TCDD) Exposure

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Maria T Landi, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-12-12
Primary Completion
2007-08-13
Completion
2020-04-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00340873 on ClinicalTrials.gov