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Recruiting Observational

Night-shift Work and Breast Cancer

NCT06786949 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-31
Last updated
2025-01-22

Condition(s) studied

Breast Cancer Risk Factors

Investigational drug(s) / intervention(s)

QuestionnaireBlood samples for biomarker measurement

Questionnaire: All cases and controls will be contacted by telephone or e-mail and invited to participate in the study. Female workers who decide to join the study will be asked to go to their company's occupational health clinic where they will undergo administration of a questionnaire to investigate possible known and unknown risk factors for breast cancer

Blood samples for biomarker measurement: Women who give consent to undergo this phase of the study will be called back to the center and will be asked to provide a blood sample

Study summary

Scientific evidence established about the effects of night work on health both in the short term (insomnia, excessive sleepiness, difficulty concentrating or lack of energy) and in the long term (moderately high risk of developing cardiovascular disease, type 2 diabetes, depression, cancer). In light of the scientific evidence, the IARC (International Agency for Research on Cancer) has listed night work as a probable human carcinogen (Group 2). With respect to current knowledge, the present study could provide valuable help in understanding the mechanisms by which circadian rhythm alteration acts at the genetic level in terms of promoting oncogenesis. Furthermore, by studying its association with other risk factors, understand whether there is a pattern of women more susceptible to its oncopromoting action.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Health workers with any type of contract and qualification (doctors, nurses, OSS) in service at IRCSS AOUBO and AOU "G. Martino" of Messina for at least six months between 1.1.2000 and 31.12.2021 * Age between 20 and 70 years at the start of study follow-up (6 months after recruitment or 1.1.2000) * Female gender * For secondary objective 2 of the study only, women exposed to night work must have worked at least 6 night shifts per month in the past six months Exclusion Criteria: * Women found to be positive for BRCA1 and BRCA2 genetic mutation (BRCA1 and 2 mutations are searched for by geneticists in sick women for whom there is a consistent suspicion of mutation) * Women with prior history of breast cancer at the time of recruitment or within six months thereafter.

Primary outcome measure(s)

  • Estimate the relationship between exposure to night work and breast cancer incidence — through study completion, an average of 1 year
    The primary objective of the study is to estimate the relationship between exposure to night work and incidence of breast cancer in a cohort of female health care workers who have been in service at IRCCS AOUBO Policlinico di S. Orsola and Azienda Ospedaliero- Universitaria "G. Martino" in Messina.

Trial sites (2)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Medicina del Lavoro Bologna Italy Recruiting
AOU G. Martino Messina U.O.S.D. Medicina del Lavoro Messina Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06786949 on ClinicalTrials.gov ↗ ← All trials in Italy