Influence of Social Determinants of Health on the Management of Hepatocellular Carcinoma in the French National Cohort Study CHIEF
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already included in the French national CHIEF cohort who accept to participate in the Social-CHIEF study.
排除标准
- •Patients included in CHIEF cohort who opposed to participate in the Social-CHIEF study.
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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 the quality of life of patients at 6 and 18 months after inclusion in the CHIEF cohort study(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)