Breast CancerE-C-HAUNCT07475325
Individual Factors Associated With Care Pathways Delays in Breast Cancer in Hauts-de-France.
An observational study of Breast Cancer and Invasive Breast Carcinoma, run by University Hospital, Lille at 34 sites in France.
Trial summary
Women in the Hauts-de-France region show higher breast cancer mortality despite no overall higher incidence, suggesting differences in the care pathway. This multicenter study will describe the overall time from the first warning sign to initiation of the first treatment, and will break down this delay into three… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Carcinoma
- How many people
- 500 participants
- Where
- 34 sitesFrance
- Study dates
- 20 Apr 2026to Mar 2028
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult women with recently diagnosed invasive breast carcinoma, receiving care in a participating Hauts-de-France center.
Who may be able to join
- Female, age ≥ 18 years.
- Confirmed invasive breast carcinoma.
- Diagnosis in 2024 (and/or < 12 months at inclusion depending on center organization).
- Affiliated with the French social security system.
- Resident of Hauts-de-France since diagnosis.
- Information provided and non-opposition documented (MR-003).
Who cannot join
- Male breast cancer.
- Other histologies (phyllodes tumor, sarcoma, lymphoma).
- Pure ductal carcinoma in situ (in situ only).
- Personal history of breast cancer (including in situ).
- Non-French-speaking.
- Person deprived of liberty.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
France34 sites
Clinique Ste Isabelle
Abbeville, 80100
CHU Amiens
Amiens, 80054
Clinique Victor Pauchet
Amiens, 80090
Centre Marie Curie
Arras, 62000
Hôpital privé Les Bonnettes
Arras, 62000
CH Beauvais
Beauvais, 60000
CH Bethune
Béthune, 62408
Centre Pierre Curie
Beuvry, 62321
CH Boulogne
Boulogne, 62321
CH Calais
Calais, 62107
CH Chauny
Chauny, 02300
Centre de Radiothérapie de Compiègne
Compiègne, 60200
Polyclinique St Côme
Compiègne, 60200
CH Compiègne
Compiègne, 60321
Clinique de Flandre
Coudekerque-Branche, 59210
Centre de Radiothérapie de Creil
Creil, 60100
Centre Leonard de Vinci
Dechy, 59187
Polyclinique de la Clarence
Divion, 62460
Institut Andrée Dutreix
Dunkirk, 59240
CH Dunkerque
Dunkirk, 59385
Polyclinique d'Hénin-Beaumont
Hénin-Beaumont, 62254
CH Lens
Lens, 62300
Centre Oscar Lambret
Lille, 59000
Hôpital privé Le Bois
Lille, 59000
Hôpital St Vincent
Lille, 59000
CHU Lille
Lille, 59037
Centre Gray
Maubeuge, 59600
CH Roubaix
Roubaix, 59100
CH St Quentin
Saint-Quentin, 02321
CH Soissons
Soissons, 02200
Clinique de la Victoire
Tourcoing, 59200
CH Tourcoing
Tourcoing, 59208
Clinique des dentellières
Valenciennes, 59300
CH Valenciennes
Valenciennes, 59322
About this study
Official title: Behavioral Economics Study of Individual Factors Influencing Time-to-care Among Women With Invasive Breast Cancer in the Hauts-de-France Region
Women in the Hauts-de-France region show higher breast cancer mortality despite no overall higher incidence, suggesting differences in the care pathway. This multicenter study will describe the overall time from the first warning sign to initiation of the first treatment, and will break down this delay into three consecutive intervals (symptoms to mammography, mammography to biopsy, biopsy to first treatment). Participants will complete a one-time questionnaire (up to 1 hour, with assistance if needed), and clinical data will be extracted in a standardized way from medical records (key dates and tumor characteristics). A random sample of 10% of incident breast cancer cases identified by each hospital information department will be used to ensure balanced geographic representation across 38 centers. The study will also explore how individual and contextual factors (psychological, behavioral, socio-demographic, access to care, communication) are associated with each time interval, and exploratory analyses will assess links with severity (metastases and prognostic score).
- Conditions
- Breast Cancer, Invasive Breast Carcinoma
- Keywords
- Breast cancer, Diagnostic delay, Time-to-treatment, Patient pathway, Behavioral economics
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time from first warning sign to initiation of first treatment.
Measured: One-time assessment using patient-reported dates and medical record dates at inclusion (single questionnaire session + record extraction). Questionnaire time : around 1 hour
Secondary outcomes (5)
Time from first warning sign to first mammography
Measured: At inclusion, one-time assessment using patient-reported dates and medical record dates.
Time from mammography to biopsy.
Measured: At inclusion, one-time assessment using patient-reported dates and medical record dates.
Time from biopsy to initiation of first treatment.
Measured: At inclusion, one-time assessment using patient-reported dates and medical record dates.
To evaluate breast cancer severity at diagnostic. Severity will be assessed by the presence of metastatic disease at diagnosis, recorded as a binary outcome (yes/no) indicating the rate of metastatic at diagnosis
Measured: At inclusion, assessed from medical record extraction.
To evaluate patients with localized breast cancer, by pronosis estimated using the PREDIC Breast tool.
Pronosis will be reported as 5-year and 10 year estimated survival probabilities, calculated from clinical variables extrected from the medical record at inclusion and expressed on a 0 to 100 % scale, with higher values indicating a better predicted outcome.
Measured: At inclusion, calculated using clinical variables extracted from the medical record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lille, Breast Cancer Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475325
- Sponsor's protocol ID
- 2025_0354
- Other IDs
- 2025-A02030-49
- Acronym
- E-C-HAU
- Status last verified
- May 2026
- First submitted
- 11 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics Study of Individual Factors Influencing Time-to-care Among Women With Invasive Breast Cancer in the Hauts-de-France Region
- ClinicalTrials.gov ID
- NCT07475325
- Acronym / sponsor ID
- E-C-HAU / 2025_0354
- Conditions
- Breast Cancer, Invasive Breast Carcinoma
- Keywords
- Breast cancer, Diagnostic delay, Time-to-treatment, Patient pathway, Behavioral economics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Université de Lille, Breast Cancer Research Foundation
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Mar 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.
Women in the Hauts-de-France region show higher breast cancer mortality despite no overall higher incidence, suggesting differences in the care pathway. This multicenter study will describe the overall time from the first warning sign to initiation of the first treatment, and will break down this delay into three consecutive intervals (symptoms to mammography, mammography to biopsy, biopsy to first treatment). Participants will complete a one-time questionnaire (up to 1 hour, with assistance if needed), and clinical data will be extracted in a standardized way from medical records (key dates and tumor characteristics). A random sample of 10% of incident breast cancer cases identified by each hospital information department will be used to ensure balanced geographic representation across 38 centers. The study will also explore how individual and contextual factors (psychological, behavioral, socio-demographic, access to care, communication) are associated with each time interval, and exploratory analyses will assess links with severity (metastases and prognostic score).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with recently diagnosed invasive breast carcinoma, receiving care in a participating Hauts-de-France center.
Key inclusion criteria (6 listed)
- Female, age ≥ 18 years.
- Confirmed invasive breast carcinoma.
- Diagnosis in 2024 (and/or < 12 months at inclusion depending on center organization).
- Affiliated with the French social security system.
- Resident of Hauts-de-France since diagnosis.
Key exclusion criteria (6 listed)
- Male breast cancer.
- Other histologies (phyllodes tumor, sarcoma, lymphoma).
- Pure ductal carcinoma in situ (in situ only).
- Personal history of breast cancer (including in situ).
- Non-French-speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total time from first warning sign to initiation of first treatment.
Time frame: One-time assessment using patient-reported dates and medical record dates at inclusion (single questionnaire session + record extraction). Questionnaire time : around 1 hour
5 secondary outcomes
Time from first warning sign to first mammography
Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.
Time from mammography to biopsy.
Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.
Time from biopsy to initiation of first treatment.
Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.
To evaluate breast cancer severity at diagnostic. Severity will be assessed by the presence of metastatic disease at diagnosis, recorded as a binary outcome (yes/no) indicating the rate of metastatic at diagnosis
Time frame: At inclusion, assessed from medical record extraction.
To evaluate patients with localized breast cancer, by pronosis estimated using the PREDIC Breast tool.
Time frame: At inclusion, calculated using clinical variables extracted from the medical record
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 12 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 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 and Invasive Breast Carcinoma, run by University Hospital, Lille at 34 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time from first warning sign to initiation of first treatment. (time frame: One-time assessment using patient-reported dates and medical record dates at inclusion (single questionnaire session + record extraction). Questionnaire time : around 1 hour). 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 12 May 2026.