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

NCT07475325 | Active Not Recruiting

• 2 other identifiers: 2025_03542025-A02030-49
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 34

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Total time from first warning sign to initiation of first treatment.

  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

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

• Time from mammography to biopsy.

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

• Time from biopsy to initiation of first treatment.

  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

  At inclusion, assessed from medical record extraction.

• To evaluate patients with localized breast cancer, by pronosis estimated using the PREDIC Breast tool.

  At inclusion, calculated using clinical variables extracted from the medical record

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Female, age ≥ 18 years.
• Confirmed invasive breast carcinoma.
• Affiliated with the French social security system.
• Resident of Hauts-de-France since diagnosis.
• Information provided and non-opposition documented (MR-003).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Université de Lille: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (34)

Clinique Ste Isabelle

Abbeville, 80100, France

Location

CHU Amiens

Amiens, 80054, France

Location

Clinique Victor Pauchet

Amiens, 80090, France

Location

Centre Marie Curie

Arras, 62000, France

Location

Hôpital privé Les Bonnettes

Arras, 62000, France

Location

CH Beauvais

Beauvais, 60000, France

Location

Centre Pierre Curie

Beuvry, 62321, France

Location

CH Bethune

Béthune, 62408, France

Location

CH Boulogne

Boulogne, 62321, France

Location

CH Calais

Calais, 62107, France

Location

CH Chauny

Chauny, 02300, France

Location

Centre de Radiothérapie de Compiègne

Compiègne, 60200, France

Location

Polyclinique St Côme

Compiègne, 60200, France

Location

CH Compiègne

Compiègne, 60321, France

Location

Clinique de Flandre

Coudekerque-Branche, 59210, France

Location

Centre de Radiothérapie de Creil

Creil, 60100, France

Location

Centre Leonard de Vinci

Dechy, 59187, France

Location

Polyclinique de la Clarence

Divion, 62460, France

Location

Institut Andrée Dutreix

Dunkirk, 59240, France

Location

CH Dunkerque

Dunkirk, 59385, France

Location

Polyclinique d'Hénin-Beaumont

Hénin-Beaumont, 62254, France

Location

CH Lens

Lens, 62300, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Hôpital privé Le Bois

Lille, 59000, France

Location

Hôpital St Vincent

Lille, 59000, France

Location

CHU Lille

Lille, 59037, France

Location

Centre Gray

Maubeuge, 59600, France

Location

CH Roubaix

Roubaix, 59100, France

Location

CH St Quentin

Saint-Quentin, 02321, France

Location

CH Soissons

Soissons, 02200, France

Location

Clinique de la Victoire

Tourcoing, 59200, France

Location

CH Tourcoing

Tourcoing, 59208, France

Location

Clinique des dentellières

Valenciennes, 59300, France

Location

CH Valenciennes

Valenciennes, 59322, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (34)