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

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 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 Bethune
      • 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
        • Hôpital Privé 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 dentellières

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

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

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

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

University Hospital, Lille

Collaborators

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)

April 20, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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