Breast Neoplasms DiagnosisNIGHT-SCANNCT07630935
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
An observational study of Breast Neoplasms Diagnosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms Diagnosis
- What is being tested?
- Personalized Prevention Plan
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2026to 8 Jul 2032
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population consists of female night staff at Pitié-Salpêtrière Hospital
Who may be able to join
- Female participants aged 18 years or older
- Night shift workers at Pitié-Salpêtrière Hospital
- Attending consultation for breast cancer risk assessment PGRC
- Affiliated with a social security system
- No personal history of breast cancer
- Provided informed consent (non-opposition procedure according to French regulations)
Who cannot join
- Pregnant or breastfeeding women
- Individuals under legal protection or deprived of liberty
- Individuals without standard health insurance coverage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pitié Salpêtrière hospital
Paris, 75013
Catherine UZAN, PU-PH, +33 01 42 17 81 14, catherine.uzan@aphp.fr
About this study
This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks.
Participants attend an initial consultation including clinical assessment and development of a personalized prevention plan targeting modifiable risk factors such as alcohol consumption, physical activity, smoking, diet, and weight.
Follow-up is conducted remotely over 5 years to assess adherence to recommendations and screening. Participant satisfaction and adherence to additional consultations are also evaluated.
Read the detailed description
Breast cancer is the most common cancer among women, and prognosis depends on early detection. Night shift work is associated with circadian rhythm disruption and increased cancer risk.
This single-center interventional study evaluates adherence to a personalized prevention plan (PPP) developed during an initial consultation. This consultation includes a review of medical history, a lifestyle assessment, and a physical examination.
The PPP targets modifiable risk factors, including smoking, alcohol consumption, diet, physical activity, and weight.
Participants are followed for 5 years, with assessments at 1, 2, 3, and 5 years. Adherence is defined as the implementation of at least one recommendation or the completion of prescribed screening tests.
Secondary objectives include assessing satisfaction with and adherence to cardiology and fertility consultations when recommended.
- Conditions
- Breast Neoplasms Diagnosis
- Being tested
- Personalized Prevention Plan
- Keywords
- Breast neoplasms, prevention & control Cancer prevention, Risk reduction behavior, Night shift work, Personalized prevention, Risk assessment
- Medical subject headings
- Breast Neoplasms, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Prevention PlanBehavioural
Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
| Study group | Role | What they receive |
|---|---|---|
| Participants with Personalized Prevention Plan | Participants receive a tailored prevention plan following risk assessment Receives: Behavioral: Personalized Prevention Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Proportion of participants adhering to at least one recommendation of the Personalized Prevention Plan or completing prescribed screening. Percentage of participants who lost weight when overweight had been identified during the initial consultation. Percentage of participants with modified sporting activity according to the recommendations at the initial consultation. Percentage of participants who had quit smoking. Percentage of participants who modified their alcohol consumption when it was excessive at the initial consultation. Percentage of participants who changed their diets when a dietary imbalance was observed during the initial consultation. Percentage of women who underwent screening as recommended following the initial consultation.
Measured: At 1, 2, 3 and 5 years.
Secondary outcomes (4)
Overal patient satisfaction
Patient satisfaction regarding the PPP will be assessed 1 year following the intervention using the validated "Patient Satisfaction Questionnaire Short Form (PSQ-18)", based on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
Measured: At 1, 2, 3 and 5 years
Participant satisfaction with the adapted consultation to night work
Satisfaction rate of women with the consultation system adapted to night. Patient satisfaction will be assessed using the validated "Patient Satisfaction Questionnaire Short Form (PSQ-18)", based on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree".
Measured: At 1, 2, 3 and 5 years.
Screening adherence to a cardiovascular consultation recommendation
Proportion of participants who had the consultation with a cardiologist when recommended
Measured: At 1, 2, 3 and 5 years.
Screening adherence to a fertility consultation consultation recommendation
Proportion of participants who had the consultation with a cardiologist when recommended
Measured: At 1, 2, 3 and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start8 Jul 2026
- Primary completion8 Jul 2032 (estimated)
- Study completion8 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasms DiagnosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine UZAN, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630935
- Sponsor's protocol ID
- APHP260459
- Acronym
- NIGHT-SCAN
- Status last verified
- Oct 2026
- First submitted
- 18 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
- ClinicalTrials.gov ID
- NCT07630935
- Acronym / sponsor ID
- NIGHT-SCAN / APHP260459
- Conditions
- Breast Neoplasms Diagnosis
- Keywords
- Breast neoplasms, prevention & control Cancer prevention, Risk reduction behavior, Night shift work, Personalized prevention, Risk assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 8 Jul 2032 (estimated)
- Study completion
- 8 Jul 2032 (estimated)
- First posted
- 5 Jun 2026 (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.
This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks.
Participants attend an initial consultation including clinical assessment and development of a personalized prevention plan targeting modifiable risk factors such as alcohol consumption, physical activity, smoking, diet, and weight.
Follow-up is conducted remotely over 5 years to assess adherence to recommendations and screening. Participant satisfaction and adherence to additional consultations are also evaluated.
Detailed description
Breast cancer is the most common cancer among women, and prognosis depends on early detection. Night shift work is associated with circadian rhythm disruption and increased cancer risk.
This single-center interventional study evaluates adherence to a personalized prevention plan (PPP) developed during an initial consultation. This consultation includes a review of medical history, a lifestyle assessment, and a physical examination.
The PPP targets modifiable risk factors, including smoking, alcohol consumption, diet, physical activity, and weight.
Participants are followed for 5 years, with assessments at 1, 2, 3, and 5 years. Adherence is defined as the implementation of at least one recommendation or the completion of prescribed screening tests.
Secondary objectives include assessing satisfaction with and adherence to cardiology and fertility consultations when recommended.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Personalized Prevention Plan | – | Behavioral: Personalized Prevention PlanParticipants receive a tailored prevention plan following risk assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of female night staff at Pitié-Salpêtrière Hospital
Key inclusion criteria (6 listed)
- Female participants aged 18 years or older
- Night shift workers at Pitié-Salpêtrière Hospital
- Attending consultation for breast cancer risk assessment PGRC
- Affiliated with a social security system
- No personal history of breast cancer
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women
- Individuals under legal protection or deprived of liberty
- Individuals without standard health insurance coverage
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 |
|---|---|---|
| Personalized Prevention PlanPersonalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening | Behavioural | Participants with Personalized Prevention Plan |
Primary outcome
Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Time frame: At 1, 2, 3 and 5 years.
Proportion of participants adhering to at least one recommendation of the Personalized Prevention Plan or completing prescribed screening. Percentage of participants who lost weight when overweight had been identified during the initial consultation. Percentage of participants with modified sporting activity according to the recommendations at the initial consultation. Percentage of participants who had quit smoking. Percentage of participants who modified their alcohol consumption when it was excessive at the initial consultation. Percentage of participants who changed their diets when a dietary imbalance was observed during the initial consultation. Percentage of women who underwent screening as recommended following the initial consultation.
4 secondary outcomes
Overal patient satisfaction
Time frame: At 1, 2, 3 and 5 years
Participant satisfaction with the adapted consultation to night work
Time frame: At 1, 2, 3 and 5 years.
Screening adherence to a cardiovascular consultation recommendation
Time frame: At 1, 2, 3 and 5 years.
Screening adherence to a fertility consultation consultation recommendation
Time frame: At 1, 2, 3 and 5 years.
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Related trials for Breast Neoplasms Diagnosis
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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.
Catherine UZAN, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms Diagnosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 3 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Catherine UZAN, PU-PH (+33 01 42 17 81 14, catherine.uzan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Personalized Prevention Plan established during the initial risk assessment consultation (time frame: At 1, 2, 3 and 5 years.). 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 20 Oct 2026.