Individual Factors Associated With Care Pathways Delays in Breast Cancer in Hauts-de-France. (E-C-HAU)

May 7, 2026 updated by: University Hospital, Lille

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Abbeville, France, 80100
        • Clinique Ste Isabelle
      • Amiens, France, 80054
        • CHU Amiens
      • Amiens, France, 80090
        • Clinique Victor Pauchet
      • Arras, France, 62000
        • Centre Marie Curie
      • Arras, France, 62000
        • Hôpital Privé les Bonnettes
      • Beauvais, France, 60000
        • CH Beauvais
      • Beuvry, France, 62321
        • Centre Pierre Curie
      • Boulogne, France, 62321
        • CH Boulogne
      • Béthune, France, 62408
        • CH Béthune
      • Calais, France, 62107
        • CH Calais
      • Chauny, France, 02300
        • CH Chauny
      • Compiègne, France, 60321
        • CH Compiègne
      • Compiègne, France, 60200
        • Centre de Radiothérapie de Compiègne
      • Compiègne, France, 60200
        • Polyclinique St Côme
      • Coudekerque-Branche, France, 59210
        • Clinique de Flandre
      • Creil, France, 60100
        • Centre de Radiothérapie de Creil
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Divion, France, 62460
        • Polyclinique de la Clarence
      • Dunkirk, France, 59385
        • CH Dunkerque
      • Dunkirk, France, 59240
        • Institut Andrée Dutreix
      • Hénin-Beaumont, France, 62254
        • Polyclinique d'Hénin-Beaumont
      • Lens, France, 62300
        • CH Lens
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lille, France, 59037
        • CHU Lille
      • Lille, France, 59000
        • Hopital prive Le Bois
      • Lille, France, 59000
        • Hôpital St Vincent
      • Maubeuge, France, 59600
        • Centre Gray
      • Roubaix, France, 59100
        • CH Roubaix
      • Saint-Quentin, France, 02321
        • CH St Quentin
      • Soissons, France, 02200
        • CH Soissons
      • Tourcoing, France, 59208
        • CH Tourcoing
      • Tourcoing, France, 59200
        • Clinique de la Victoire
      • Valenciennes, France, 59322
        • CH Valenciennes
      • Valenciennes, France, 59300
        • Clinique des Dentellieres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult women with recently diagnosed invasive breast carcinoma, receiving care in a participating Hauts-de-France center.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
One-time assessment using patient-reported dates and medical record dates at inclusion (single questionnaire session + record extraction). Questionnaire time : around 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from first warning sign to first mammography
Time Frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.
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.
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.
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.
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
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.
At inclusion, calculated using clinical variables extracted from the medical record

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Breast Cancer Research Foundation
Université de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025_0354
  • 2025-A02030-49 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings