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Clinical Trials in France / NCT06550687
Recruiting Not applicable

Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.

NCT06550687 · tracked via the Priya Life Science France tracker
Sponsor
Centre Georges Francois Leclerc
Phase
Not applicable
Started
2024-09-19
Last updated
2025-02-18

Condition(s) studied

All Types of Metastatic Solid Malignancy1st-line TreatmentExome AnalysisActive File EXOMA2 Study

Investigational drug(s) / intervention(s)

Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis

Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis: Phase 1: Observation of doctor-patient consultations Phase 2: Adaptation of information tools Phase 3: Assessment of understanding of information tools

Study summary

Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.

The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient identified for inclusion in the EXOMA 2 study (exome analysis request) * Available to receive different types of information * Fluent in French * No prior oncogenetic consultation * Having been informed of the objectives of the study and having given written non-objection to participate in the INFOGene study * Authorizing audio recording of consultations and interviews Exclusion Criteria: * Patient who refused to participate in the EXOMA2 study (for phase 3 patients only) * Has a psychiatric, cognitive or neurological disorder that makes participation impossible * Working in the field of genetics

Primary outcome measure(s)

  • Concepts of communication and preferences. — Through study completion, an average of 21 months.
    The various interviews (phases 1 and 3) will provide an insight into patients' level of health literacy, which may explain the ease or difficulty of exchanges with the doctor (phase 1), as well as patients' preferences for one type of information over another (phase 3).

Trial sites (2)

FacilityCityRegionStatus
Centre Georges-François Leclerc Dijon France Recruiting
CHU François Mitterand Dijon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06550687 on ClinicalTrials.gov ↗ ← All trials in France