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NCT Number: NCT07475325

Individual Factors Associated With Care Pathways Delays in Breast Cancer in Hauts-de-France.

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Invasive Breast Carcinoma Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Ste Isabelle, Abbeville, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Time from first warning sign to first mammography

    Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.

  2. Time from mammography to biopsy.

    Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.

  3. Time from biopsy to initiation of first treatment.

    Time frame: At inclusion, one-time assessment using patient-reported dates and medical record dates.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Breast Cancer Research Foundation
  • Université de Lille

Registry information

Official study title

Behavioral Economics Study of Individual Factors Influencing Time-to-care Among Women With Invasive Breast Cancer in the Hauts-de-France Region

Acronym: E-C-HAU

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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