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Hepatocellular CarcinomaSOCIAL-CHIEFNCT05128123

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

An observational study of Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
How many people
1,600 participants
Where
1 siteFrance
Study dates
21 Jan 2022to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients (18 years old and older) with newly diagnosed or already known HCC that are eligible for systemic treatments and already included in the national CHIEF cohort.

Who may be able to join

  • Patients already included in the French national CHIEF cohort who accept to participate in the Social-CHIEF study.

Who cannot join

  • Patients included in CHIEF cohort who opposed to participate in the Social-CHIEF study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Anna M Borowik

    La Tronche, Auvergne-Rhône-Alpes, 38700

Other trials in France

About this study

Official title: Influence of Social Determinants of Health on the Management of Hepatocellular Carcinoma in the French National Cohort Study CHIEF

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.

Keywords
Hepatocellular Carcinoma, Primary Liver Cancer, Social determinants of health
Medical subject headings
Carcinoma, Hepatocellular

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Up to 3 months

Secondary outcomes (4)

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

    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.

    Measured: Up to 3 months

  2. Assessment of the relationship between social health determinants and one-year survival

    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.

    Measured: Up to 3 months

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

    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.

    Measured: Up to 3 months

  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

    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.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start21 Jan 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128123
Sponsor's protocol ID
38RC21.0295
Acronym
SOCIAL-CHIEF
Status last verified
Apr 2025
First submitted
28 Oct 2021
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costentin CE, Mourad A, Lahmek P, Causse X, Pariente A, Hagege H, Dobrin AS, Becker C, Marks B, Bader R, Condat B, Heluwaert F, Seitz JF, Lesgourgues B, Denis J, Deuffic-Burban S, Rosa I, Decaens T; CHANGH Study Group. Hepatocellular carcinoma is diagnosed at a later stage in alcoholic patients: Results of a prospective, nationwide study. Cancer. 2018 May 1;124(9):1964-1972. doi: 10.1002/cncr.31215. Epub 2018 Mar 28.

    PubMed 29589878

  • Damiani G, Basso D, Acampora A, Bianchi CB, Silvestrini G, Frisicale EM, Sassi F, Ricciardi W. The impact of level of education on adherence to breast and cervical cancer screening: Evidence from a systematic review and meta-analysis. Prev Med. 2015 Dec;81:281-9. doi: 10.1016/j.ypmed.2015.09.011. Epub 2015 Sep 25.

    PubMed 26408405

  • Herbert C, Launoy G, Gignoux M. Factors affecting compliance with colorectal cancer screening in France: differences between intention to participate and actual participation. Eur J Cancer Prev. 1997 Feb;6(1):44-52. doi: 10.1097/00008469-199702000-00008.

    PubMed 9161812

  • Jembere N, Campitelli MA, Sherman M, Feld JJ, Lou W, Peacock S, Yoshida E, Krahn MD, Earle C, Thein HH. Influence of socioeconomic status on survival of hepatocellular carcinoma in the Ontario population; a population-based study, 1990-2009. PLoS One. 2012;7(7):e40917. doi: 10.1371/journal.pone.0040917. Epub 2012 Jul 13.

    PubMed 22808283

  • Singal AG, Li X, Tiro J, Kandunoori P, Adams-Huet B, Nehra MS, Yopp A. Racial, social, and clinical determinants of hepatocellular carcinoma surveillance. Am J Med. 2015 Jan;128(1):90.e1-7. doi: 10.1016/j.amjmed.2014.07.027. Epub 2014 Aug 10.

    PubMed 25116425

  • Clark PJ, Stuart KA, Leggett BA, Crawford DH, Boyd P, Fawcett J, Whiteman DC, Baade PD. Remoteness, race and social disadvantage: disparities in hepatocellular carcinoma incidence and survival in Queensland, Australia. Liver Int. 2015 Dec;35(12):2584-94. doi: 10.1111/liv.12853. Epub 2015 May 22.

    PubMed 25900432

  • Bryere J, Dejardin O, Bouvier V, Colonna M, Guizard AV, Troussard X, Pornet C, Galateau-Salle F, Bara S, Launay L, Guittet L, Launoy G. Socioeconomic environment and cancer incidence: a French population-based study in Normandy. BMC Cancer. 2014 Feb 13;14:87. doi: 10.1186/1471-2407-14-87.

    PubMed 24524213

  • Tron L, Belot A, Fauvernier M, Remontet L, Bossard N, Launay L, Bryere J, Monnereau A, Dejardin O, Launoy G; French Network of Cancer Registries (FRANCIM). Socioeconomic environment and disparities in cancer survival for 19 solid tumor sites: An analysis of the French Network of Cancer Registries (FRANCIM) data. Int J Cancer. 2019 Mar 15;144(6):1262-1274. doi: 10.1002/ijc.31951. Epub 2018 Dec 3.

    PubMed 30367459

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128123, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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