Last reviewed · How we verify

NCT00340873

Molecular Epidemiology of Dioxin-Related Illness in Seveso

Completed Last updated 20 April 2020
What this trial tests

trial in 2,3,7,8-Tetrachlorodibenzo-Para-Dioxin (TCDD) Exposure in 300 participants. Completed in 16 April 2020.

Timeline
12 December 1994
Primary endpoint
13 August 2007
16 April 2020

Quick facts

Lead sponsorNational Cancer Institute (NCI)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment300
Start date12 December 1994
Primary completion13 August 2007
Estimated completion16 April 2020
Sites1 location across Italy

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 100, any sex, with 2,3,7,8-Tetrachlorodibenzo-Para-Dioxin (TCDD) Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation.
    Polonio CM, McHale KA, Sherr DH, Rubenstein D, et al · · 2025 · cited 41× · PMID 40247142 · DOI 10.1038/s41573-025-01172-x

Verify or expand the search:

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00340873.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing