Night-shift Work and Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Medicina del Lavoro
RECRUITING
Bologna
AOU G. Martino Messina U.O.S.D. Medicina del Lavoro
RECRUITING
Messina
Contact Information
Primary
Francesco Violante Violante, MD
francesco.violante@asop.bo.it
051 2142611
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 6000
Treatments
Subgroup 1
For the analysis of possible risk factors for breast cancer (secondary objective 1), a nested case-control study will be conducted on a subpopulation of the health worker cohort: 100 cases will be selected from the health workers in the cohort who have been diagnosed with breast cancer; 3 healthy controls will be selected for each case (300 total) and will be matched to the cases based on center, age, and period of first employment
Subgroup 2
For the measurement of biomarkers of aging whose expression might be associated with night shifts (secondary objective 2), 200 health care workers who have been exposed to at least 6 night shifts per month in the past 6 months and 200 unexposed health care workers, plus 50 other health care workers in each group to prevent possible nonadherence to the study, will be randomly selected from the cohort of health care workers currently still in service.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov