Breast Cancer Risk FactorsBC-NSW-02/2023NCT06786949
Night-shift Work and Breast Cancer
An observational study of Breast Cancer Risk Factors, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Risk Factors
- What is being tested?
- Questionnaire and Blood samples for biomarker measurement
- How many people
- 6,000 participants
- Where
- 2 sitesItaly
- Study dates
- 31 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Health care workers with an employment relationship at IRCCS AOUBO Policlinico di S. Orsola and AOU "G. Martino" of Messina undergoing health surveillance, aged between 20 and 70 years at the time of recruitment (from January 1, 2000 until December 31, 2021).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Medicina del Lavoro
Bologna, 40138
Francesco Violante, MD, 051 2142611, francesco.violante@asop.bo.it
Francesco Violante, MD
- Recruiting
AOU G. Martino Messina U.O.S.D. Medicina del Lavoro
Messina, 98125
Concettina Fenga, MD, 090 2211, concettina.fenga@unime.it
Concettina Fenga, MD
About this study
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.
Read the detailed description
Certain bodily functions, such as wakefulness and sleep, regulation of blood pressure and body temperature, the immune system, gene expression, and secretion of hormones--think of cortisol, for example--follow variations that are stably repeated every 24 to 25 hours. The biological clock that marks this cyclical rhythm is represented by neurons in the suprachiasmatic nucleus of the hypothalamus. Of the circadian system, three components should be considered: (a) the input pathways that transmit signals to synchronize the endogenous central clock with the external environment, (b) the central clock generates rhythms, and (c) the output pathways that transmit the signal from the central clock to other regulatory systems in the brain and body. The most powerful regulator of the input pathways is light, which-as is well known-is captured by the five retinal photoreceptors, including the intrinsically photosensitive retinal ganglion cells [ipRGCs], which, through the production of melanopsin, transmit the signal to the central circadian clock. Such physiological mechanisms, which have remained unperturbed for thousands of years, have been disrupted by the spread of artificial lighting, which, inevitably, alters the natural synchronization of the internal clock with sunlight.
The effects that this misalignment produces are clearly visible in night workers who frequently have to expose themselves to light at "atypical" hours. In this sense, in fact, according to current legislation (see Art. 1, Legislative Decree No. 66 of April 8, 2003, implementing Directives 93/104/EC and 2000/34/EC, concerning certain aspects of the organization of working time), a night worker is defined as anyone who works for a period of at least seven consecutive hours including the interval between midnight and 5 a.m. It follows with palpable evidence that there is an increased risk that, under night work conditions, the alteration of the sleep-wake rhythm may take on a chronic character. In this regard, scientific evidence about the effects of night work on short-term health is well established: such as insomnia, excessive sleepiness, difficulty in concentration or lack of energy. While there is also scientific evidence that some repercussions may also occur in the long term. This is, in that case, the moderately high risk of developing cardiovascular disease, type 2 diabetes, depression, and, not least, cancer. Indeed, in 2007, in light of scientific evidence, the IARC (International Agency for Research on Cancer) listed night work as a probable human carcinogen (Group 2). Breast cancer generally represents the second most frequent neoplastic disease in women. The incidence of new cases worldwide in 2017 was estimated to be 1.9 million, higher in industrialized countries. From a pathogenetic point of view, the association between night shift work and breast cancer is highly plausible.
- Conditions
- Breast Cancer Risk Factors
- Being tested
- Questionnaire, Blood samples for biomarker measurement
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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 measurementDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire | |
| 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. Receives: Diagnostic Test: Blood samples for biomarker measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the relationship between exposure to night work and breast cancer incidence
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Identify by case-control analysis which risk factors are associated with the development of breast cancer
identify by case-control analysis which risk factors are associated with the development of breast cancer and evaluate their effect on the relationship between exposure to night work and breast cancer occurrence among female health workers in the selected cohort
Measured: Six months from the start of follow-up
Determine whether epigenetic alterations are more prevalent in the genome of women exposed to night work
Determine whether epigenetic alterations attributable to the effect of altered sleep-wake rhythm are more present in the genome of women exposed to night work than in women not exposed to night work.
Measured: At enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Violante, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786949
- Sponsor's protocol ID
- BC-NSW-02/2023
- Other IDs
- PNRR-MAD-2022-12376823
- Acronym
- BC-NSW-02/2023
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night-shift Work and Breast Cancer
- ClinicalTrials.gov ID
- NCT06786949
- Acronym / sponsor ID
- BC-NSW-02/2023 / BC-NSW-02/2023
- Conditions
- Breast Cancer Risk Factors
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Certain bodily functions, such as wakefulness and sleep, regulation of blood pressure and body temperature, the immune system, gene expression, and secretion of hormones--think of cortisol, for example--follow variations that are stably repeated every 24 to 25 hours. The biological clock that marks this cyclical rhythm is represented by neurons in the suprachiasmatic nucleus of the hypothalamus. Of the circadian system, three components should be considered: (a) the input pathways that transmit signals to synchronize the endogenous central clock with the external environment, (b) the central clock generates rhythms, and (c) the output pathways that transmit the signal from the central clock to other regulatory systems in the brain and body. The most powerful regulator of the input pathways is light, which-as is well known-is captured by the five retinal photoreceptors, including the intrinsically photosensitive retinal ganglion cells [ipRGCs], which, through the production of melanopsin, transmit the signal to the central circadian clock. Such physiological mechanisms, which have remained unperturbed for thousands of years, have been disrupted by the spread of artificial lighting, which, inevitably, alters the natural synchronization of the internal clock with sunlight.
The effects that this misalignment produces are clearly visible in night workers who frequently have to expose themselves to light at "atypical" hours. In this sense, in fact, according to current legislation (see Art. 1, Legislative Decree No. 66 of April 8, 2003, implementing Directives 93/104/EC and 2000/34/EC, concerning certain aspects of the organization of working time), a night worker is defined as anyone who works for a period of at least seven consecutive hours including the interval between midnight and 5 a.m. It follows with palpable evidence that there is an increased risk that, under night work conditions, the alteration of the sleep-wake rhythm may take on a chronic character. In this regard, scientific evidence about the effects of night work on short-term health is well established: such as insomnia, excessive sleepiness, difficulty in concentration or lack of energy. While there is also scientific evidence that some repercussions may also occur in the long term. This is, in that case, the moderately high risk of developing cardiovascular disease, type 2 diabetes, depression, and, not least, cancer. Indeed, in 2007, in light of scientific evidence, the IARC (International Agency for Research on Cancer) listed night work as a probable human carcinogen (Group 2). Breast cancer generally represents the second most frequent neoplastic disease in women. The incidence of new cases worldwide in 2017 was estimated to be 1.9 million, higher in industrialized countries. From a pathogenetic point of view, the association between night shift work and breast cancer is highly plausible.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1 | – | Other: QuestionnaireFor 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 | – | Diagnostic Test: Blood samples for biomarker measurementFor 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers with an employment relationship at IRCCS AOUBO Policlinico di S. Orsola and AOU "G. Martino" of Messina undergoing health surveillance, aged between 20 and 70 years at the time of recruitment (from January 1, 2000 until December 31, 2021).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAll 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 | Other | Subgroup 1 |
| Blood samples for biomarker measurementWomen 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 | Diagnostic test | Subgroup 2 |
Primary outcome
Estimate the relationship between exposure to night work and breast cancer incidence
Time frame: 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.
2 secondary outcomes
Identify by case-control analysis which risk factors are associated with the development of breast cancer
Time frame: Six months from the start of follow-up
Determine whether epigenetic alterations are more prevalent in the genome of women exposed to night work
Time frame: At enrollment in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Violante, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Risk Factors, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Violante Violante, MD (051 2142611, francesco.violante@asop.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the relationship between exposure to night work and breast cancer incidence (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.