SOCIAL-CHIEF: Influence of Social Determinants of Health on the Management of HCC in the French National Cohort Study CHIEF

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05128123
Collaborator
University Grenoble Alps (Other), University Hospital, Caen (Other), Amiens University Hospital (Other), National Cancer Institute, France (Other)
1,600
Enrollment
1
Location
60
Anticipated Duration (Months)
26.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With 8,000 related deaths per year, HCC is one of the most dangerous cancers in France. The main reason for the poor prognosis of HCC is most often a diagnosis at an advanced stage ineligible for curative treatment. In the field of oncology, low participation to screening is closely linked to socioeconomic status (e.g. level of education, income, employment). In HCC, the socioeconomic status is linked to incidence, overall survival and treatment allocation in US, UK and Australia. This suggests that the social environment should be taken into account when designing interventions and policies that allows facilitating the medical pathways for patients with HCC with the ultimate goal of improving the overall prognosis. However, the studies assessing the impact of social determinants on the management of HCC in France are limited. Bryère at al. reported that the highest incidence and the worst prognosis of HCC were observed in the most disadvantaged populations in France. To date, there is no available data concerning the influence of social determinants on: implementation of surveillance programs of HCC, stage of disease at the time of diagnosis or treatment allocation. This data is essential for better understanding the geographic disparities observed in France and for developing the strategies to remedy them.

CHIEF is a multicenter longitudinal observational study of patients with HCC (ClinicalTrials.gov Identifier: NCT04348838), that will collect the exhaustive data including patient and tumor characteristics, diagnostic circumstances and modalities, care pathway from diagnostic imaging to referral to expert center, treatment allocation and implementation, and 5-year follow up including recurrent assessment of quality of life.

Social-CHIEF is an ancillary study to the CHIEF cohort (approved by CHIEF scientific committee). The population of this study will consist in a subset of patients from the CHIEF prospectively included or already recruited who accept to participate in this study. The data collected in CHIEF will be retrieved from the CHIEF main database and additional data about social determinants will be specifically investigated by self-administrated questionnaires. The results obtained will provide a better understanding of the influence of social determinants on health trajectories of HCC patients. These data will be essential in recommending new health policies and in designing innovative intervention studies to address social disparities.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Influence of Social Determinants of Health on the Management of Hepatocellular Carcinoma in the French National Cohort Study CHIEF
    Anticipated Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective will be to assess the rates of curative treatment (either resection, ablation or liver transplantation) according to the social determinants of health [Up to 3 months]

      Treatment allocation will be retrieved from the CHIEF eCRF and categorized into curative treatment (either ablation, resection or liver transplant) or non-curative treatments (all other treatment options). Rates of curative treatments will be described across categories of the different social determinants of health. Crude and adjusted relative risks between these determinants and the primary outcome will be estimated using a generalized linear regression model.

    Secondary Outcome Measures

    1. Describe the underlying etiology, clinical and biological characteristics of HCC, diagnostic modalities, therapeutic management according to social determinants of health [Up to 3 months]

      Descriptive analysis of the underlying etiology, patient characteristics and tumor stage at the time of diagnosis, diagnostic methods (as part of the surveillance program vs. incidental), therapeutic management (curative vs. non-curative) and distribution of the different treatment modalities (transplantation, resection, percutaneous destruction, chemoembolization, intra-arterial radiotherapy, systemic treatments), compliance with management recommendations and care pathways, according to indicators of social determinants of health.

    2. Assessment of the relationship between social health determinants and one-year survival [Up to 3 months]

      Progression-free survival (PFS) and overall survival (OS) parameters that will be retrieved from the CHIEF eCRF. The determinants of PFS and OS at one-year will be assessed using a survival model.

    3. Assessment of the relationship between social health determinants and quality indicators for the management of HCC (diagnosis at 2 years after treatment) [Up to 3 months]

      The quality indicators for the management of HCC will be retrieved from the CHIEF eCRF. The determinants of the quality indicators for the management of HCC (from diagnosis to 2 years after treatment) will be evaluated using a logistic regression model.

    4. Assessment of the relationship between social health determinants and the quality of life of patients at 6 and 18 months after inclusion in the CHIEF cohort study [Up to 3 months]

      The quality of life of patients is assessed using the EQ-5D-5L questionnaire, the QLQ-C30 questionnaire and its module HCC18 specific to the HCC at different time points (6 months and 18 months from inclusion) during the follow-up in the CHIEF cohort. The determinants of a degraded quality of life will be evaluated using logistic regression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients already included in the French national CHIEF cohort who accept to participate in the Social-CHIEF study.
    Exclusion Criteria:
    • Patients included in CHIEF cohort who opposed to participate in the Social-CHIEF study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Anna M BorowikLa TroncheAuvergne-Rhône-AlpesFrance38700

    Sponsors and Collaborators

    • University Hospital, Grenoble
    • University Grenoble Alps
    • University Hospital, Caen
    • Amiens University Hospital
    • National Cancer Institute, France

    Investigators

    • Principal Investigator: Charlotte E Costentin, Pr, University Hospital, Grenoble

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT05128123
    Other Study ID Numbers:
    • 38RC21.0295
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021