Sleep Apnoea Syndrome and Hepatocellular Carcinoma

NCT ID: NCT04190498

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-04-12

Brief Summary

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

Detailed Description

Obstructive Sleep Apnea (OSA) is a common respiratory disease characterized by the occurrence of recurrent episodes of partial or total obstruction of the upper airway called hypopneas and apneas respectively. These episodes are associated with the repetitive occurrence of the desaturation-reoxygenation sequences, the so-called chronic intermittent hypoxia (IH) which is the major stimulus underlying main cardiovascular, metabolic consequences and pro-inflammatory state found in patients with OSA. Recent data from cohort studies have established that OSA is an even greater risk factor for cancer-related mortality. Hepatocellular carcinoma (HCC) is the second cancer related death worldwide and has an increasing impact in developed countries. The epidemic of metabolic syndrome (MS) plays a growing role in the occurrence of metabolic steatohepatitis (NASH) related HCC. Concerning transition from NASH to NASH-related HCC, neither the frequency nor the underlying mechanism are known. Very recently, a link between OSA (IH) and NASH has been highlighted. OSA and intermittent hypoxia should be a major worsening factor in a neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC in a context of NASH.

The objective is to compare the prevalence of OSA between patients with NASH-related and hepatitis C virus (HCV)-related HCC. In this type 3, cross-sectional, multicenter, national, non-randomized study patients suffering from a NASH-related or HCV-related hepatocellular carcinoma will be recruited. Investigators expect to show a higher prevalence of OSA in patients with HCC NASH-related but also a shorter overall survival. Complementary ex vivo studies on tumor samples will be conducted in order to explore the mechanisms by which OSA and IH would promote carcinogenesis

Conditions

Sleep Apnea, Obstructive; Hepatocellular Carcinoma; Non Alcoholic Steato Hepatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NASH-related HCC

The study is focused on patients suffering from NASH-induced HCC. Each patient with NASH-related HCC will be paired with 2 patients with non NASH-related HCC (HCV-induced CHC).

Nocturnal oximetry

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes

HCV-related HCC

HCV-related HCC has been chosen as control population for several reasons: HCV represent a common etiology of HCC; with a distinct pathophysiology distinct from that of post-NASH HCC; populations with post-NASH and post-HCV CHC share similar epidemiological characteristics.

Nocturnal oximetry

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes

Interventions

Nocturnal oximetry

Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Man and woman
• >18 years
• Diagnosis of NASH-induced HCC or HCV-induced HCC
• Patients treated by surgical excision
• Patients not opposed to the study

Exclusion Criteria

• Patient refusal
• Alcohol consumption> 20g / day for women and> 30g / day for men
• Patient with HCV genotype 3
• Tumor vascular invasion identified preoperatively
• Other etiologies of hepatopathies (alcoholic, viral B, autoimmune, hemochromatosis)
• Other chronic respiratory diseases: chronic obstructive pulmonary disease, respiratory insufficiency
• Patient weight variation >5% since surgical treatment of his HCC
• Subject deprived of liberty or under guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis Pépin, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Thomas Decaens, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Minovés-Kotzki

La Tronche, Rhones-Alpes, France

Countries

France

Other Identifiers

2018-A02400-55

Identifier Type: OTHER

Identifier Source: secondary_id

38RC17.410

Identifier Type: -

Identifier Source: org_study_id