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

NCT05128123 | Active Not Recruiting

• 1 other identifier: 38RC21.0295
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Primary Liver Cancer; Social determinants of health

Outcome Measures

Primary Outcomes (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.

  Up to 3 months

Secondary Outcomes (4)

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

  Up to 3 months

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

  Up to 3 months

• 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

• 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

Eligibility Criteria

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

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Anna M Borowik

La Tronche, Auvergne-Rhône-Alpes, 38700, France

Location

Related Publications (8)

• 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.

  PMID: 29589878 BACKGROUND

• 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.

  PMID: 26408405 BACKGROUND

• 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.

  PMID: 9161812 BACKGROUND

• 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.

  PMID: 22808283 BACKGROUND

• 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.

  PMID: 25116425 BACKGROUND

• 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.

  PMID: 25900432 BACKGROUND

• 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.

  PMID: 24524213 BACKGROUND

• 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.

  PMID: 30367459 BACKGROUND

Related Links

• INSERM CépiDc - Causes of death from 1979 to 2014

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Charlotte E Costentin, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 19, 2021
• Study Start: January 21, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)